Method and apparatus for body fluid sampling with improved sensing

ABSTRACT

A device is provided for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature. The device comprises a cartridge having a plurality of cavities. The device may include a plurality of penetrating members each at least partially contained in the cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from openings on the cartridge to penetrate tissue. The device may also include a plurality of analyte detecting members and a plurality of chambers. Each chamber may be associated with one of the cavities, the chambers positioned along an outer periphery of the cartridge, wherein at least one of said analyte detecting members forms a portion of one wall of one of said plurality of chambers. In one embodiment, the device may also include a fluid spreader positioned over at least a portion of said analyte detecting member to urge fluid toward one of the detecting members.

RELATED APPLICATIONS

This application is a continuation-in-part of commonly assigned,copending U.S. patent application Ser. No. 10/324,053 filed on Dec. 18,2002, which is a continuation-in-part of commonly assigned, U.S. patentapplication Ser. No. 10/127,395 now U.S Pat. No. 7,025,774 filed Apr.19, 2002. This application is also a continuation-in-part of commonlyassigned, copending U.S. patent application Ser. No. 10/237,261 Sept. 5,2002. This application is further a continuation-in-part of commonlyassigned, copending U.S. patent application Ser. No. 10/420,535 filedApr. 21, 2003. This application is further a continuation-in-part ofcommonly assigned copending U.S. patent application Ser. No.10/423,851now U.S. Pat. No. 7,141,058 filed Apr. 24, 2003. This application alsoclaims the benefit of priority from commonly assigned, copending U.S.Provisional Patent Application Ser. No. 60/393,706 Jul.1, 2002; commonlyassigned, copending U.S. Provisional Patent Application Ser. No.60/393,707 filed Jul 1, 2002; commonly assigned, copending U.S.Provisional Patent Application Ser. No. 60/422,988 filed Nov. 1, 2002;commonly assigned, copending U.S. Provisional Patent Application Ser.No. 60/424,429 filed Nov. 6, 2002; and commonly assigned, copending U.S.Provisional Patent Application Ser. No. 60/428,084 filed Nov. 20, 2002.All applications listed above are incorporated herein by reference forall purposes.

BACKGROUND OF THE INVENTION

Lancing devices are known in the medical health-care products industryfor piercing the skin to produce blood for analysis. Typically, a dropof blood for this type of analysis is obtained by making a smallincision in the fingertip, creating a small wound, which generates asmall blood droplet on the surface of the skin.

Early methods of lancing included piercing or slicing the skin with aneedle or razor. Current methods utilize lancing devices that contain amultitude of spring, cam and mass actuators to drive the lancet. Theseinclude cantilever springs, diaphragms, coil springs, as well as gravityplumbs used to drive the lancet. The device may be held against the skinand mechanically triggered to ballistically launch the lancet.Unfortunately, the pain associated with each lancing event using knowntechnology discourages patients from testing. In addition to vibratorystimulation of the skin as the driver impacts the end of a launcherstop, known spring based devices have the possibility of firing lancetsthat harmonically oscillate against the patient tissue, causing multiplestrikes due to recoil. This recoil and multiple strikes of the lancet isone major impediment to patient compliance with a structured glucosemonitoring regime.

Another impediment to patient compliance is the lack of spontaneousblood flow generated by known lancing technology. In addition to thepain as discussed above, a patient may need more than one lancing eventto obtain a blood sample since spontaneous blood generation isunreliable using known lancing technology. Thus the pain is multipliedby the number of attempts required by a patient to successfully generatespontaneous blood flow. Different skin thickness may yield differentresults in terms of pain perception, blood yield and success rate ofobtaining blood between different users of the lancing device. Knowndevices poorly account for these skin thickness variations.

A still further impediment to improved compliance with glucosemonitoring are the many steps and inconvenience associated with eachlancing event. Many diabetic patients that are insulin dependent mayneed to self-test for blood glucose levels five to six times daily. Thelarge number of steps required in traditional methods of glucosetesting, ranging from lancing, to milking of blood, applying blood to atest strip, and getting the measurements from the test strip,discourages many diabetic patients from testing their blood glucoselevels as often as recommended. Older patients and those withdeteriorating motor skills encounter difficulty loading lancets intolauncher devices, transferring blood onto a test strip, or insertingthin test strips into slots on glucose measurement meters. Additionally,the wound channel left on the patient by known systems may also be of asize that discourages those who are active with their hands or who areworried about healing of those wound channels from testing their glucoselevels.

SUMMARY OF THE INVENTION

The present invention provides solutions for at least some of thedrawbacks discussed above. Specifically, some embodiments of the presentinvention provide a multiple lancet solution to measuring analyte levelsin the body. The invention may use a high density design. The inventionmay provide an indicator of the point of impact of a lancet orpenetrating member used to sample fluid from tissue. At least some ofthese and other objectives described herein will be met by embodimentsof the present invention.

In one embodiment of the present invention, a device is provided for usewith a body fluid sampling device for extracting bodily fluid from ananatomical feature. The device comprises a cartridge having a pluralityof cavities. The device may include a plurality of penetrating memberseach at least partially contained in the cavities of the cartridgewherein the penetrating members are slidably movable to extend outwardfrom openings on the cartridge to penetrate tissue. The device may alsoinclude a plurality of analyte detecting members and a plurality ofchambers. Each chamber may be associated with one of the cavities, thechambers positioned along an outer periphery of the cartridge, whereinat least one of the analyte detecting members forms a portion of onewall of one of the plurality of chambers. In one embodiment, the devicemay also include a fluid spreader positioned over at least a portion ofthe analyte detecting member to urge fluid toward one of the detectingmembers.

The penetrating members may each have a tip, wherein at least one tiphas a starting position in the chamber. The analyte detecting membersmay be electrochemical. In one embodiment, at least one of the chambersincludes an opening on one of its surfaces, wherein one of the analytedetecting members is visible through the opening.

In another embodiment, the present invention provides a device for usewith a body fluid sampling device for extracting bodily fluid from ananatomical feature. The device comprises a cartridge having a pluralityof sample chambers and a plurality of penetrating members each at leastpartially contained in the sample chambers of the single cartridgewherein the penetrating members are slidably movable to extend outwardfrom openings on the cartridge to penetrate tissue. A plurality ofanalyte detecting members may be included. The chambers may bepositioned substantially adjacent an outer periphery of the cartridge,wherein at least one of the analyte detecting members forms a portion ofone wall of one of the plurality of sample chambers.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating a system, according to anembodiment for use in piercing skin to obtain a blood sample;

FIG. 2 is a plan view of a portion of a replaceable penetrating membercartridge forming part of the system;

FIG. 3 is a cross-sectional end view on 3-3 in FIG. 2;

FIG. 4 is a cross-sectional end view on 4-4 in FIG. 2;

FIG. 5 is a perspective view of an apparatus forming part of the systemand used for manipulating components of the cartridge, illustratingpivoting of a penetrating member accelerator in a downward direction;

FIG. 6A is a view similar to FIG. 5, illustrating how the cartridge isrotated or advanced;

FIG. 6B is a cross-sectional side view illustrating how the penetratingmember accelerator allows for the cartridge to be advanced;

FIGS. 7A and 7B are views similar to FIGS. 6A and 6B, respectively,illustrating pivoting of the penetrating member accelerator in anopposite direction to engage with a select one of the penetratingmembers in the cartridge;

FIGS. 8A and 8B are views similar to FIGS. 7A and 7B, respectively,illustrating how the penetrating member accelerator moves the selectedpenetrating member to pierce skin;

FIGS. 9A and 9B are views similar to FIGS. 8A and 8B, respectively,illustrating how the penetrating member accelerator returns thepenetrating member to its original position;

FIG. 10 is a block diagram illustrating functional components of theapparatus; and

FIG. 11 is an end view illustrating a cartridge according to an optionalembodiment that allows for better adhesion of sterilization barriers.

FIG. 12 is a cross-sectional view of an embodiment having features ofthe invention.

FIG. 13 is a cross-sectional view of an embodiment having features ofthe invention in operation.

FIG. 14 is a cross-sectional view illustrating a low-friction coatingapplied to one penetrating member contact surface.

FIG. 15 is a cross-sectional view illustrating a coating applied to onepenetrating member contact surface which increases friction and improvesthe microscopic contact area between the penetrating member and thepenetrating member contact surface.

FIG. 16 illustrates a portion of a penetrating member cartridge havingan annular configuration with a plurality of radially orientedpenetrating member slots and a distal edge of a drive member disposed inone of the penetrating member slots.

FIG. 17 is an elevational view in partial longitudinal section of acoated penetrating member in contact with a coated penetrating membercontact surface.

FIG. 18 illustrates an embodiment of a lancing device having features ofthe invention.

FIG. 19 is a perspective view of a portion of a penetrating membercartridge base plate having a plurality of penetrating member slots anddrive member guide slots disposed radially inward of and aligned withthe penetrating member slots.

FIGS. 20-22 illustrate a penetrating member cartridge in section, adrive member, a penetrating member and the tip of a patient's fingerduring three sequential phases of a lancing cycle.

FIG. 23 illustrates an embodiment of a penetrating member cartridgehaving features of the invention.

FIG. 24 is an exploded view of a portion of the penetrating membercartridge of FIG. 12.

FIGS. 25 and 26 illustrate a multiple layer sterility barrier disposedover a penetrating member slot being penetrated by the distal end of apenetrating member during a lancing cycle.

FIGS. 27 and 28 illustrate an embodiment of a drive member coupled to adriver wherein the drive member includes a cutting member having asharpened edge which is configured to cut through a sterility barrier ofa penetrating member slot during a lancing cycle in order for the drivemember to make contact with the penetrating member.

FIGS. 29 and 30 illustrate an embodiment of a penetrating member slot inlongitudinal section having a ramped portion disposed at a distal end ofthe penetrating member slot and a drive member with a cutting edge at adistal end thereof for cutting through a sterility barrier during alancing cycle.

FIGS. 31-34 illustrate drive member slots in a penetrating membercartridge wherein at least a portion of the drive member slots have atapered opening which is larger in transverse dimension at the top ofthe drive member slot than at the bottom of the drive member slot.

FIGS. 35-37 illustrate an embodiment of a penetrating member cartridgeand penetrating member drive member wherein the penetrating member drivemember has a contoured jaws configured to grip a penetrating membershaft.

FIGS. 38 and 39 show a portion of a lancing device having a lid that canbe opened to expose a penetrating member cartridge cavity for removal ofa used penetrating member cartridge and insertion of a new penetratingmember cartridge.

FIGS. 40 and 41 illustrate a penetrating member cartridge that haspenetrating member slots on both sides.

FIGS. 42-44 illustrate end and perspective views of a penetrating membercartridge having a plurality of penetrating member slots formed from acorrugated surface of the penetrating member cartridge.

FIGS. 45-48 illustrate embodiments of a penetrating member and drivemember wherein the penetrating member has a slotted shaft and the drivemember has a protuberance configured to mate with the slot in thepenetrating member shaft.

FIG. 49 is a perspective view of a cartridge according to the presentinvention.

FIGS. 50 and 51 show close-ups of outer peripheries various cartridges.

FIG. 52 is a perspective view of an underside of a cartridge.

FIG. 53A shows a top down view of a cartridge and the punch and pusherdevices.

FIG. 53B is a perspective view of one embodiment of a punch plate.

FIGS. 54A-54G show a sequence of motion for the punch plate, thecartridge, and the cartridge pusher.

FIGS. 55A-55B show cross-sections of the system according to the presentinvention.

FIG. 56A shows a perspective view of the system according to the presentinvention.

FIGS. 56B-56D are cut-away views showing mechanisms within the presentinvention.

FIGS. 57-65B show optional embodiments according to the presentinvention.

FIGS. 66-68 shows a still further embodiment of a cartridge according tothe present invention.

FIGS. 69A-69L show the sequence of motions associated with an optionalembodiment of a cartridge according to the present invention.

FIGS. 70-72 show views of a sample modules used with still furtherembodiments of a cartridge according to the present invention.

FIG. 73 shows a cartridge with a sterility barrier and an analytedetecting member layer.

FIGS. 74-78 show still further embodiments of analyte detecting memberscoupled to a cartridge.

FIGS. 79-84 show optional configurations for a cartridge for use withthe present invention.

FIG. 85 shows a see-through view of one embodiment of a system accordingto the present invention.

FIG. 86 is a schematic of an optional embodiment of a system accordingto the present invention.

FIGS. 87A-87B show still further embodiments of cartridges according tothe present invention.

FIG. 88 shows a cartridge having an array of analyte detecting members.

FIGS. 89-90 show embodiments of illumination systems for use with thepresent invention.

FIGS. 91-96 show further embodiments using optical methods for analytedetection.

FIG. 97 shows a chart of varying penetrating member velocity indifferent parts of the tissue.

FIG. 98 shows a cross-sectional view of a light source used with aimingthe driver.

FIGS. 99 and 100 show cross-sectional views of housings having a lightsource used with aiming the driver.

FIGS. 101 and 102 show a housing wherein a portion is made of a clearmaterial.

FIG. 103 shows a cartridge, sterility barrier, and a substrate accordingto the present invention.

FIGS. 104-105 show perspective views of one embodiment of the presentinvention.

FIGS. 106-107 show perspective views of an underside of one embodimentof the present invention.

FIGS. 108 and 109 show a top view and bottom view of a furtherembodiment of a cartridge according to the present invention.

FIGS. 110 and 111 show a top perspective view and a bottom perspectiveview of a further embodiment of a cartridge according to the presentinvention.

FIG. 112 shows additional embodiments for use with the presentinvention.

FIGS. 113-115 show various views of a still further embodiment of acartridge and analyte detecting members according to the presentinvention.

FIGS. 116 and 117 show a top view and bottom view of a furtherembodiment of a cartridge according to the present invention.

FIGS. 118-119 shows additional embodiments for use with the presentinvention.

FIG. 120 is a top down view of a cartridge using a fluid spreader overthe analyte detecting member.

FIGS. 121-123 are perspective views of further embodiments of acartridge according to the present invention.

FIGS. 124-125 show kits according to the present invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention provides a multiple analyte detecting membersolution for body fluid sampling. Specifically, some embodiments of thepresent invention provides a multiple analyte detecting member andmultiple lancet solution to measuring analyte levels in the body. Theinvention may use a high density design. It may use lancets of smallersize, such as but not limited to diameter or length, than known lancets.The device may be used for multiple lancing events without having toremove a disposable from the device. The invention may provide improvedsensing capabilities. At least some of these and other objectivesdescribed herein will be met by embodiments of the present invention.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed. It must be notedthat, as used in the specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a material”may include mixtures of materials, reference to “a chamber” may includemultiple chambers, and the like. References cited herein are herebyincorporated by reference in their entirety, except to the extent thatthey conflict with teachings explicitly set forth in this specification.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

-   -   “Optional” or “optionally” means that the subsequently described        circumstance may or may not occur, so that the description        includes instances where the circumstance occurs and instances        where it does not. For example, if a device optionally contains        a feature for analyzing a blood sample, this means that the        analysis feature may or may not be present, and, thus, the        description includes structures wherein a device possesses the        analysis feature and structures wherein the analysis feature is        not present.

“Analyte detecting member” refers to any use, singly or in combination,of chemical test reagents and methods, electrical test circuits andmethods, physical test components and methods, optical test componentsand methods, and biological test reagents and methods to yieldinformation about a blood sample. Such methods are well known in the artand may be based on teachings of, e.g. Tietz Textbook of ClinicalChemistry, 3d Ed., Sec. V, pp. 776-78 (Burtis & Ashwood, Eds., W.B.Saunders Company, Philadelphia, 1999); U.S. Pat. No. 5,997,817 toChrismore et al. (Dec. 7, 1999); U.S. Pat. No. 5,059,394 to Phillips etal. (Oct. 22, 1991); U.S. Pat. No. 5,001,054 to Wagner et al. (Mar. 19,1991); and U.S. Pat. No. 4,392,933 to Nakamura et al. (Jul. 12, 1983),the teachings of which are hereby incorporated by reference, as well asothers. Analyte detecting member may include tests in the sample testchamber that test electrochemical properties of the blood, or they mayinclude optical means for sensing optical properties of the blood (e.g.oxygen saturation level), or they may include biochemical reagents (e.g.antibodies) to sense properties (e.g. presence of antigens) of theblood. The analyte detecting member may comprise biosensing or reagentmaterial that will react with an analyte in blood (e.g. glucose) orother body fluid so that an appropriate signal correlating with thepresence of the analyte is generated and can be read by the readerapparatus. By way of example and not limitation, analyte detectingmember may be “associated with”, “mounted within”, or “coupled to” achamber or other structure when the analyte detecting memberparticipates in the function of providing an appropriate signal aboutthe blood sample to the reader device. Analyte detecting member may alsoinclude nanowire analyte detecting members as described herein. Analytedetecting member may use any, singly or in combination, potentiometric,coulometric, or other method useful for detection of analyte levels.

FIGS. 1-11 of the accompanying drawings illustrates one embodiment of asystem 10 for piercing tissue to obtain a blood sample. The system 10may include a replaceable cartridge 12 and an apparatus 14 for removablyreceiving the cartridge 12 and for manipulating components of thecartridge 12.

Referring jointly to FIGS. 1 and 2, the cartridge 12 may include aplurality of penetrating members 18. The cartridge 12 may be in the formof a circular disc and has an outer circular surface 20 and an openingforming an inner circular surface 22. A plurality of grooves 24 areformed in a planar surface 26 of the cartridge 12. Each groove 24 iselongated and extends radially out from a center point of the cartridge12. Each groove 24 is formed through the outer circular surface 20.Although not shown, it should be understood that the grooves 24 areformed over the entire circumference of the planar surface 26. As shownin FIGS. 3 and 4, each groove 24 is relatively narrow closer to thecenter point of the cartridge 12 and slightly wider further from thecenter point. These grooves 24 may be molded into the cartridge 12,machined into the cartridge, forged, pressed, or formed using othermethods useful in the manufacture of medical devices.

In the present embodiment, each penetrating member 18 has an elongatedbody 26 and a sharpened distal end 27 having a sharp tip 30. Thepenetrating member 18 may have a circular cross-section with a diameterin this embodiment of about 0.315 mm. All outer surfaces of thepenetrating member 18 may have the same coefficient of friction. Thepenetrating member may be, but is not necessarily, a bare lancet. Thelancet is “bare”, in the sense that no raised formations or molded partsare formed thereon that are complementarily engageable with anotherstructure. Traditional lancets include large plastic molded parts thatare used to facilitate engagement. Unfortunately, such attachments addsize and cost. In the most basic sense, a bare lancet or barepenetrating member is an elongate wire having sharpened end. If it is ofsufficiently small diameter, the tip may be penetrating without havingto be sharpened. A bare lancet may be bent and still be considered abare lancet. The bare lancet in one embodiment may be made of onematerial.

In the present embodiment, each penetrating member 18 is located in arespective one of the grooves 24. The penetrating members 18 have theirsharpened distal ends 27 pointed radially out from the center point ofthe cartridge 12. A proximal end of each penetrating member 15 mayengage in an interference fit with opposing sides of a respective groove24 as shown in FIG. 3. Other embodiments of the cartridge 12 may not usesuch an interference fit. As a nonlimiting example, they may use afracturable adhesive to releasably secure the penetrating member 18 tothe cartridge 12. As shown in FIG. 4, more distal portions of thepenetrating member 18 are not engaged with the opposing sides of thegroove 24 due to the larger spacing between the sides.

The cartridge 12 may further include a sterilization barrier 28 attachedto the upper surface 26. The sterilization barrier 28 is located overthe penetrating members 18 and serves to insulate the penetratingmembers 18 from external contaminants. The sterilization barrier 28 ismade of a material that can easily be broken when an edge of a deviceapplies a force thereto. The sterilization barrier 28 alone or incombination with other barriers may be used to create a sterileenvironment about at least the tip of the penetrating member prior tolancing or actuation. The sterilization barrier 28 may be made of avariety of materials such as but not limited to metallic foil, aluminumfoil, paper, polymeric material, or laminates combining any of theabove. Other details of the sterilization barrier are detailed herein.

In the present embodiment, the apparatus 14 may include a housing 30, aninitiator button 32, a penetrating member movement subassembly 34, acartridge advance subassembly 36, batteries 38, a capacitor 40, amicroprocessor controller 42, and switches 44. The housing 30 may have alower portion 46 and a lid 48. The lid 48 is secured to the lowerportion 46 with a hinge 50. The lower portion 46 may have a recess 52. Acircular opening 54 in the lower portion 46 defines an outer boundary ofthe recess 52 and a level platform 56 of the lower portion 46 defines abase of the recess 52.

In use, the lid 48 of the present embodiment is pivoted into a positionas shown in FIG. 1. The cartridge 12 is flipped over and positioned inthe recess 52. The planar surface 26 rests against the level platform 56and the circular opening 54 contacts the outer circular surface 20 toprevent movement of the cartridge 12 in a plane thereof. The lid 48 isthen pivoted in a direction 60 and closes the cartridge 12.

Referring to the embodiment shown in FIG. 5, the penetrating membermovement subassembly 34 includes a lever 62, a penetrating memberaccelerator 64, a linear actuator 66, and a spring 68. Other suitableactuators including but not limited to rotary actuators are described incommonly assigned, copending U.S. patent application Ser. No. 10/127,395filed Apr. 19, 2002. The lever 62 may be pivotably secured to the lowerportion 46. The button 32 is located in an accessible position externalof the lower portion 46 and is connected by a shaft 70 through the lowerportion 46 to one end of the lever 62. The penetrating memberaccelerator 64 is mounted to an opposing end of the lever 62. A userdepresses the button 32 in an upward direction 66 so that the shaft 70pivots the end of the lever 62 to which it is connected in an upwarddirection. The opposing end of the lever pivots in a downward direction66. The spring 46 is positioned between the button 32 and the base 40and compresses when the button 32 is depressed to create a force thattends to move the button 32 down and pivot the penetrating memberaccelerator upward in a direction opposite to the direction 64.

Referring to FIGS. 6A and 6B in this particular embodiment, the movementof the button into the position shown in FIG. 5 also causes contactbetween a terminal 74 on the shaft 20 with a terminal 70 secured to thelower portion 46. Contact between the terminals 74 and 76 indicates thatthe button 32 has been fully depressed. With the button 32 depressed,the cartridge 12 can be rotated without interference by the penetratingmember actuator 64. To this effect, the cartridge advancer subsystem 36includes a pinion gear 80 and a stepper motor 82. The stepper motor 82is secured to the lower portion 46. The pinion gear 80 is secured to thestepper motor 82 and is rotated by the stepper motor 82. Teeth on thepinion gear 80 engage with teeth on the inner circular surface 22 of thecartridge 12. Rotation of the pinion gear 80 causes rotation of thecartridge 12 about the center point thereof. Each time that theterminals 74 and 76 make contact, the stepper motor 82 is operated torotate the cartridge 12 through a discrete angle equal to an angularspacing from a centerline of one of the penetrating members 18 to acenterline of an adjacent penetrating member. A select penetratingmember 18 is so moved over the penetrating member accelerator 64, asshown in FIG. 6B. Subsequent depressions of the button 32 will causerotation of subsequent adjacent penetrating members 18 into a positionover the penetrating member accelerator 64.

The user then releases pressure from the button, as shown in FIG. 7A.The force created by the spring 68 or other resilient member moves thebutton 32 in a downward direction 76. The shaft 70 is pivotably securedto the lever 62 so that the shaft 70 moves the end of the lever 62 towhich it is connected down. The opposite end of the lever 62 pivots thepenetrating member accelerator 64 upward in a direction 80. As shown inFIG. 7B, an edge 82 of the penetrating member accelerator 64 breaksthrough a portion of the sterilization barrier 28 and comes in tophysical contact with a lower side surface of the penetrating member 18.

Referring to FIG. 8A, the linear actuator 66 includes separate advancingcoils 86A and retracting coils 86B, and a magnetizable slug 90 withinthe coils 86A and 86B. The coils 86A and 86B are secured to the lowerportion of 46, and the slug 90 can move within the coils 86A and 88B.Once the penetrating member accelerator 64 is located in the positionshown in FIGS. 7A and 7B, electric current is provided to the advancingcoils 86 only. The current in the advancing coils 86 creates a force ina direction 88 on the slug 90 according to conventional principlesrelating to electromagnetics.

A bearing 91 is secured to the lever and the penetrating memberaccelerator 64 has a slot 92 over the bearing 91. The slot 92 allows forthe movement of the penetrating member accelerator 64 in the direction88 relative to the lever 62, so that the force created on the slug movesthe penetrating member accelerator 64 in the direction 88.

The spring 68 is not entirely relaxed, so that the spring 68, throughthe lever 62, biases the penetrating member accelerator 64 against thelower side surface of the penetrating member 18 with a force F1. Thepenetrating member 18 rests against a base 88 of the cartridge 12. Anequal and opposing force F2 is created by the base 88 on an upper sidesurface of the penetrating member 18.

The edge 82 of the penetrating member accelerator 64 has a much highercoefficient of friction than the base 88 of the cartridge 12. The highercoefficient of friction of the edge contributes to a relatively highfriction force F3 on the lower side surface of the penetrating member18. The relatively low coefficient of friction of the base 88 creates arelatively small friction force F4 on the upper side surface of thepenetrating member 18. A difference between the force F3 and F4 is aresultant force that accelerates the penetrating member in the direction88 relative to the cartridge 12. The penetrating member is moved out ofthe interference fit illustrated in FIG. 3. The bare penetrating member18 is moved without the need for any engagement formations on thepenetrating member. Current devices, in contrast, often make use aplastic body molded onto each penetrating member to aid in manipulatingthe penetrating members. Movement of the penetrating member 18 moves thesharpened end thereof through an opening 90 in a side of the lowerportion 46. The sharp end 30 of the penetrating member 18 is therebymoved from a retracted and safe position within the lower portion 46into a position wherein it extends out of the opening 90. Accelerated,high-speed movement of the penetrating member is used so that the sharptip 30 penetrates skin of a person. A blood sample can then be takenfrom the person, typically for diabetic analysis.

Reference is now made to FIGS. 9A and 9B. After the penetrating memberis accelerated (for example, but not limitation, less than 0.25 secondsthereafter), the current to the accelerating coils 86A is turned off andthe current is provided to the retracting coils 86B. The slug 90 movesin an opposite direction 92 together with the penetrating memberaccelerator 64. The penetrating member accelerator 64 then returns theused penetrating member into its original position, i.e., the same asshown in FIG. 7B.

Subsequent depression of the button as shown in FIG. 5 will then causeone repetition of the process described, but with an adjacent sterilepenetrating member. Subsequent sterile penetrating members can so beused until all the penetrating members have been used, i.e., after onecomplete revolution of the cartridge 12. In this embodiment, a secondrevolution of the cartridge 12 is disallowed to prevent the use ofpenetrating members that have been used in a previous revolution andhave become contaminated. The only way in which the user can continue touse the apparatus 14 is by opening ‘the lid 48 as shown in FIG. 1,removing the used cartridge 12, and replacing the used cartridge withanother cartridge. A detector (not shown) detects whenever a cartridgeis removed and replaced with another cartridge. Such a detector may bebut is not limited to an optical sensor, an electrical contact sensor, abar code reader, or the like.

FIG. 10 illustrates the manner in which the electrical components may befunctionally interconnected for the present embodiment. The battery 38provides power to the capacitor 40 and the controller 42. The terminal76 is connected to the controller 42 so that the controller recognizeswhen the button 32 is depressed. The capacitor to provide power(electric potential and current) individually through the switches (suchas field-effect transistors) to the advancing coils 86A, retractingcoils 86B and the stepper motor 82. The switches 44A, B, and C are allunder the control of the controller 42. A memory 100 is connected to thecontroller. A set of instructions is stored in the memory 100 and isreadable by the controller 42. Further functioning of the controller 42in combination with the terminal 76 and the switches 44A, B, and Cshould be evident from the foregoing description.

FIG. 11 illustrates a configuration for another embodiment of acartridge having penetrating members. The cartridge 112 has a corrugatedconfiguration and a plurality of penetrating members 118 in grooves 124formed in opposing sides of the cartridge 112. Sterilization barriers126 and 128 are attached over the penetrating members 118 at the top andthe penetrating members 118 at the bottom, respectively. Such anarrangement provides large surfaces for attachment of the sterilizationbarriers 126 and 128. All the penetrating members 118 on the one sideare used first, whereafter the cartridge 112 is turned over and thepenetrating members 118 on the other side are used. Additional aspectsof such a cartridge are also discussed in FIGS. 42-44.

Referring now to FIGS. 12-13, a friction based method of coupling withand driving bare lancets or bare penetrating members will be describedin further detail. Any embodiment of the present invention disclosedherein may be adapted to use these methods. As seen in FIG. 12, surface201 is physically in contact with penetrating member 202. Surface 203 isalso physically in contact with penetrating member 202. In the presentembodiment of the invention, surface 201 is stainless steel, penetratingmember 202 is stainless steel, and surface 203 ispolytetrafluoroethylene-coated stainless steel.

FIG. 13 illustrates one embodiment of the friction based coupling inuse. Normal force 206 may be applied vertically to surface 201, pressingit against penetrating member 202. Penetrating member 202 is therebypressed against surface 203. Normal force 206 is transmitted throughsurface 201 and penetrating member 202 to also act between penetratingmember 202 and surface 203. Surface 203 is held rigid or stationary withrespect to a target of the lancet. Using the classical static frictionmodel, the maximum frictional force between surface 201 and penetratingmember 202 is equal to the friction coefficient between surface 201 andpenetrating member 202 multiplied by the normal force between surface201 and penetrating member 202. In this embodiment, the maximumfrictional force between surface 203 and penetrating member 202 is equalto the coefficient of friction between the surface 203 and thepenetrating member 202 multiplied by the normal force betweenthe-surface 203 and the penetrating member 202. Because frictioncoefficient between surface 203 and penetrating member 202 is less thanfriction coefficient between surface 201 and penetrating member 202, theinterface between surface 201 and penetrating member 202 can develop ahigher maximum static friction force than can the interface betweensurface 203 and penetrating member 202.

Driving force as indicated by arrow 207 is applied to surface 201perpendicular to normal force 206. The sum of the forces actinghorizontally on surface 201 is the sum of driving force 207 and thefriction force developed at the interface of surface 201 and penetratingmember 202, which acts in opposition to driving force 207. Since thecoefficient of friction between surface 203 and penetrating member 202is less than the coefficient of friction between surface 201 andpenetrating member 202, penetrating member 202 and surface 201 willremain stationary with respect to each other and can be considered tobehave as one piece when driving force 207 just exceeds the maximumfrictional force that can be supported by the interface between surface203 and penetrating member 202. Surface 201 and penetrating member 202can be considered one piece because the coefficient of friction betweensurface 201 and penetrating member 202 is high enough to preventrelative motion between the two.

In one embodiment, the coefficient of friction between surface 201 andpenetrating member 202 is approximately 0.8 corresponding to thecoefficient of friction between two surfaces of stainless steel, whilethe coefficient of friction between surface 203 and penetrating member202 is approximately 0.04, corresponding to the coefficient of frictionbetween a surface of stainless steel and one of polytetrafluoroethylene.Normal force 206 has a value of 202 Newtons. Using these values, themaximum frictional force that the interface between surface 201 andpenetrating member 202 can support is 1.6 Newtons, while the maximumfrictional force that the interface between surface 203 and penetratingmember 202 can support is 0.08 Newtons. If driving force 207 exceeds0.08 Newtons, surface 201 and penetrating member 202 will begin toaccelerate together with respect to surface 203. Likewise, if drivingforce 207 exceeds 1.6 Newtons and penetrating member 202 encounters arigid barrier, surface 201 would move relative to penetrating member202.

Another condition, for example, for surface 201 to move relative topenetrating member 202 would be in the case of extreme acceleration. Inan embodiment, penetrating member 202 has a mass of 8.24×10-6 kg. Anacceleration of 194,174 m/s2 of penetrating member 202 would thereforebe required to exceed the frictional force between penetrating member202 and surface 201, corresponding to approximately 19,800 g's. Withoutbeing bound to any particular embodiment or theory of operation, othermethods of applying friction base coupling may also be used. Forexample, the penetrating member 202 may be engaged by a coupler using ainterference fit to create the frictional engagement with the member.

FIG. 14 illustrates a polytetrafluoroethylene coating on stainless steelsurface 203 in detail. It should be understood that the surface 203 maybe coated with other materials such as but not limited to Telfon®,silicon, polymer or glass. The coating may cover all of the penetratingmember, only the proximal portions, only the distal portions, only thetip, only some other portion, or some combination of some or all of theabove. FIG. 15 illustrates a doping of lead applied to surface 201,which conforms to penetrating member 202 microscopically when pressedagainst it. Both of these embodiments and other coated embodiments of apenetrating member may be used with the actuation methods describedherein.

The shapes and configurations of surface 201 and surface 102 could besome form other than shown in FIGS. 12-15. For example, surface 201could be the surface of a wheel, which when rotated causes penetratingmember 202 to advance or retract relative to surface 203. Surface 201could be coated with another conformable material besides lead, such asa plastic. It could also be coated with particles, such as diamond dust,or given a surface texture to enhance the friction coefficient ofsurface 201 with penetrating member 202. Surface 202 could be made of orcoated with diamond, fluorinated ethylene propylene, perfluoroalkoxy, acopolymer of ethylene and tetrafluoroethylene, a copolymer of ethyleneand chlorotrifluoroethylene, or any other material with a coefficient offriction with penetrating member 202 lower than that of the materialused for surface 201.

Referring to FIG. 16, a portion of a base plate 210 of an embodiment ofa penetrating member cartridge is shown with a plurality of penetratingmember slots 212 disposed in a radial direction cut into a top surface214 of the base plate. A drive member 216 is shown with a distal edge218 disposed within one of the penetrating member slots 212 of the baseplate 210. The distal edge 218 of the drive member 216 is configured toslide within the penetrating member slots 212 with a minimum of frictionbut with a close fit to minimize lateral movement during a lancingcycle.

FIG. 17 shows a distal portion 220 of a coated penetrating member 222 inpartial longitudinal section. The coated penetrating member 222 has acore portion 224, a coating 226 and a tapered distal end portion 228. Aportion of a coated drive member 230 is shown having a coating 234 withpenetrating member contact surface 236. The penetrating member contactsurface 236 forms an interface 238 with an outer surface 240 of thecoated penetrating member 222. The interface 238 has a characteristicfriction coefficient that will depend in part on the choice of materialsfor the penetrating member coating 226 and the drive member coating 234.If silver is used as the penetrating member and drive member coating 226and 236, this yields a friction coefficient of about 1.3 to about 1.5.Other materials can be used for coatings 226 and 236 to achieve thedesired friction coefficient. For example, gold, platinum, stainlesssteel and other materials may be used for coatings 226 and 236. It maybe desirable to use combinations of different materials for coatings 226and 236. For example, an embodiment may include silver for a penetratingmember coating 226 and gold for a drive member coating. Some embodimentsof the interface 238 can have friction coefficients of about 1.15 toabout 5.0, specifically, about 1.3 to about 2.0.

Embodiments of the penetrating member 222 can have an outer transversedimension or diameter of about 200 to about 400 microns, specifically,about 275 to about 325 microns. Embodiments of penetrating member 222can have a length of about 10 to about 30 millimeters, specifically,about 15 to about 25 millimeters. Penetrating member 222 can be madefrom any suitable high strength alloy such as stainless steel or thelike.

FIG. 18 is a perspective view of a lancing device 242 having features ofthe invention. A penetrating member cartridge 244 is disposed about adriver 246 that is coupled to a drive member 248 by a coupler rod 250.The penetrating member cartridge 244 has a plurality of penetratingmember slots 252 disposed in a radial configuration in a top surface 254a base plate 256 of the penetrating member cartridge 244. The distalends 253 of the penetrating member slots 252 are disposed at an outersurface 260 of the base plate 256. A fracturable sterility barrier 258,shown partially cut away, is disposed on the top surface 254 of baseplate 256 over the plurality of penetrating member slots 252. Thesterility barrier 258 is also disposed over the outer surface 260 of thebase plate 256 in order to seal the penetrating member slots fromcontamination prior to a lancing cycle. A distal portion of apenetrating member 262 is shown extending radially from the penetratingmember cartridge 244 in the direction of a patient's finger 264.

FIG. 19 illustrates a portion of the base plate 256 used with thelancing device 242 in more detail and without sterility barrier 258 inplace (for ease of illustration). The base plate 256 includes aplurality of penetrating member slots 252 which are in radial alignmentwith corresponding drive member slots 266. The drive member slots 266have an optional tapered input configuration that may facilitatealignment of the drive member 248 during downward movement into thedrive member slot 266 and penetrating member slot 252. Penetratingmember slots 252 are sized and configured to accept a penetrating member262 disposed therein and allow axial movement of the penetrating member262 within the penetrating member slots 252 without substantial lateralmovement.

Referring again to FIG. 18, in use, the present embodiment ofpenetrating member cartridge 242 is placed in an operationalconfiguration with the driver 246. A lancing cycle is initiated and thedrive member 248 is brought down through the sterility barrier 258 andinto a penetrating member slot 252. A penetrating member contact surfaceof the drive member then makes contact with an outside surface of thepenetrating member 262 and is driven distally toward the patient'sfinger 264 as described above with regard to the embodiment discussed inFIG. 20. The friction coefficient between the penetrating member contactsurface of the drive member 248 and the penetrating member 262 isgreater than the friction coefficient between the penetrating member 262and an interior surface of the penetrating member slots 252. As such,the drive member 248 is able to drive the penetrating member 262distally through the sterility barrier 258 and into the patient's finger264 without any relative movement or substantial relative movementbetween the drive member 248 and the penetrating member 262.

Referring to FIGS. 20-22, a lancing cycle sequence is shown for alancing device 242 with another embodiment of a penetrating membercartridge 244 as shown in FIGS. 23 and 24. The base plate 256 of thepenetrating member cartridge 242 shown in FIGS. 23 and 24 has aplurality of penetrating member slots 252 with top openings 268 that donot extend radially to the outer surface 260 of the base plate 256. Inthis way, the penetrating member slots 252 can be sealed with a firststerility barrier 270 disposed on the top surface 254 of the base plate256 and a second sterility barrier 272 disposed on the outer surface 260of the base plate 256. Penetrating member outlet ports 274 are disposedat the distal ends of the penetrating member slots 252.

Referring again to FIG. 20, the penetrating member 262 is shown in theproximally retracted starting position within the penetrating memberslot 252. The outer surface of the penetrating member 276 is in contactwith the penetrating member contact surface 278 of the drive member 248.The friction coefficient between the penetrating member contact surface278 of the drive member 248 and the outer surface 276 of the penetratingmember 262 is greater than the friction coefficient between thepenetrating member 262 and an interior surface 280 of the penetratingmember slots 252. A distal drive force as indicated by arrow 282 in FIG.10 is then applied via the drive coupler 250 to the drive member 248 andthe penetrating member is driven out of the penetrating member outletport 274 and into the patient's finger 264. A proximal retraction force,as indicated by arrow 284 in FIG. 22, is then applied to the drivemember 248 and the penetrating member 262 is withdrawn from thepatient's finger 264 and back into the penetrating member slot 252.

FIGS. 25 and 26 illustrate an embodiment of a multiple layer sterilitybarrier 258 in the process of being penetrated by a penetrating member62. It should be understood that this barrier 258 may be adapted for usewith any embodiment of the present invention. The sterility barrier 258shown in FIGS. 25 and 26 is a two layer sterility barrier 258 thatfacilitates maintaining sterility of the penetrating member 262 as itpasses through and exits the sterility barrier 258. In FIG. 25, thedistal end 286 of the penetrating member 262 is applying an axial forcein a distal direction against an inside surface 288 of a first layer 290of the sterility barrier 258, so as to deform the first layer 290 of thesterility barrier 258. The deformation 291 of the first layer 290 inturn applies a distorting force to the second layer 292 of the sterilitybarrier 258. The second layer of the sterility barrier is configured tohave a lower tensile strength that the first layer 290. As such, thesecond layer 292 fails prior to the first layer 290 due to the strainimposed on the first layer 290 by the distal end 286 of the penetratingmember 262, as shown in FIG. 26. After the second layer 292 fails, itthen retracts from the deformed portion 291 of the first layer 290 asshown by arrows 294 in FIG. 26. As long as the inside surface 288 andoutside surface 296 of the first layer 290 are sterile prior to failureof the second layer 292, the penetrating member 262 will remain sterileas it passes through the first layer 290 once the first layer eventuallyfails. Such a multiple layer sterility barrier 258 can be used for anyof the embodiments discussed herein. The multiple layer sterilitybarrier 258 can also include three or more layers.

Referring to FIGS. 27 and 28, an embodiment of a drive member 300coupled to a driver 302 wherein the drive member 300 includes a cuttingmember 304 having a sharpened edge 306 which is configured to cutthrough a sterility barrier 258 of a penetrating member slot 252 duringa lancing cycle in order for the drive member 300 to make contact with apenetrating member. An optional lock pin 308 on the cutting member 304can be configured to engage the top surface 310 of the base plate inorder to prevent distal movement of the cutting member 304 with thedrive member 300 during a lancing cycle.

FIGS. 29 and 30 illustrate an embodiment of a penetrating member slot316 in longitudinal section having a ramped portion 318 disposed at adistal end 320 of the penetrating member slot. A drive member 322 isshown partially disposed within the penetrating member slot 316. Thedrive member 322 has a cutting edge 324 at a distal end 326 thereof forcutting through a sterility barrier 328 during a lancing cycle. FIG. 30illustrates the cutting edge 324 cutting through the sterility barrier328 during a lancing cycle with the cut sterility barrier 328 peelingaway from the cutting edge 324.

FIGS. 31-34 illustrate drive member slots in a base plate 330 of apenetrating member cartridge wherein at least a portion of the drivemember slots have a tapered opening which is larger in transversedimension at a top surface of the base plate than at the bottom of thedrive member slot. FIG. 31 illustrates a base plate 330 with apenetrating member slot 332 that is tapered at the input 334 at the topsurface 336 of the base plate 330 along the entire length of thepenetrating member slot 332. In such a configuration, the penetratingmember slot and drive member slot (not shown) would be in communicationand continuous along the entire length of the slot 332. As an optionalalternative, a base plate 338 as shown in FIGS. 32 and 33 can have adrive member slot 340 that is axially separated from the correspondingpenetrating member slot 342. With this configuration, the drive memberslot 340 can have a tapered configuration and the penetrating memberslot 342 can have a straight walled configuration. In addition, thisconfiguration can be used for corrugated embodiments of base plates 346as shown in FIG. 34. In FIG. 34, a drive member 348 is disposed within adrive member slot 350. A penetrating member contact surface 352 isdisposed on the drive member 348. The contact surface 352 has a taperedconfiguration that will facilitate lateral alignment of the drive member348 with the drive member slot 350.

FIGS. 35-37 illustrate an embodiment of a penetrating member cartridge360 and drive member 362 wherein the drive member 362 has contoured jaws364 configured to grip a penetrating member shaft 366. In FIG. 35, thedrive member 362 and penetrating member shaft 366 are shown intransverse cross section with the contoured jaws 364 disposed about thepenetrating member shaft 366. A pivot point 368 is disposed between thecontoured jaws 364 and a tapered compression slot 370 in the drivemember 362. A compression wedge 372 is shown disposed within the taperedcompression slot 370. Insertion of the compression wedge 372 into thecompression slot 370 as indicated by arrow 374, forces the contouredjaws 364 to close about and grip the penetrating member shaft 366 asindicated by arrows 376.

FIG. 36 shows the drive member 362 in position about a penetratingmember shaft 366 in a penetrating member slot 378 in the penetratingmember cartridge 360. The drive member can be actuated by the methodsdiscussed above with regard to other drive member and driverembodiments. FIG. 37 is an elevational view in longitudinal section ofthe penetrating member shaft 166 disposed within the penetrating memberslot 378. The arrows 380 and 382 indicate in a general way, the pathfollowed by the drive member 362 during a lancing cycle. During alancing cycle, the drive member comes down into the penetrating memberslot 378 as indicated by arrow 380 through an optional sterility barrier(not shown). The contoured jaws of the drive member then clamp about thepenetrating member shaft 366 and move forward in a distal direction soas to drive the penetrating member into the skin of a patient asindicated by arrow 382.

FIGS. 38 and 39 show a portion of a lancing device 390 having a lid 392that can be opened to expose a penetrating member cartridge cavity 394for removal of a used penetrating member cartridge 396 and insertion ofa new penetrating member cartridge 398. Depression of button 400 in thedirection indicated by arrow 402 raises the drive member 404 from thesurface of the penetrating member cartridge 396 by virtue of leveraction about pivot point 406. Raising the lid 392 actuates the lever arm408 in the direction indicated by arrow 410 which in turn applies atensile force to cable 412 in the direction indicated by arrow 414. Thisaction pulls the drive member back away from the penetrating membercartridge 396 so that the penetrating member cartridge 396 can beremoved from the lancing device 390. A new penetrating member cartridge398 can then be inserted into the lancing device 390 and the steps abovereversed in order to position the drive member 404 above the penetratingmember cartridge 398 in an operational position.

FIGS. 40 and 41 illustrate a penetrating member cartridge 420 that haspenetrating member slots 422 on a top side 424 and a bottom side 426 ofthe penetrating member cartridge 420. This allows for a penetratingmember cartridge 420 of a diameter D to store for use twice the numberof penetrating members as a one sided penetrating member cartridge ofthe same diameter D.

FIGS. 42-44 illustrate end and perspective views of a penetrating membercartridge 430 having a plurality of penetrating member slots 432 formedfrom a corrugated surface 434 of the penetrating member cartridge 430.Penetrating members 436 are disposed on both sides of the penetratingmember cartridge 430. A sterility barrier 438 is shown disposed over thepenetrating member slots 432 in FIG. 44.

FIGS. 45-48 illustrate embodiments of a penetrating member 440 and drivemember 442 wherein the penetrating member 440 has a transverse slot 444in the penetrating member shaft 446 and the drive member 442 has aprotuberance 448 configured to mate with the transverse slot 444 in thepenetrating member shaft 446. FIG. 45 shows a protuberance 448 having atapered configuration that matches a tapered configuration of thetransverse slot 444 in the penetrating member shaft 446. FIG. 46illustrates an optional alternative embodiment wherein the protuberance448 has straight walled sides that are configured to match the straightwalled sides of the transverse slot 444 shown in FIG. 46. FIG. 47 showsa tapered protuberance 448 that is configured to leave an end gap 450between an end of the protuberance 448 and a bottom of the transverseslot in the penetrating member shaft 446.

FIG. 48 illustrates a mechanism 452 to lock the drive member 442 to thepenetrating member shaft 446 that has a lever arm 454 with an optionalbearing 456 on the first end 458 thereof disposed within a guide slot459 of the drive member 442. The lever arm 454 has a pivot point 460disposed between the first end 458 of the lever arm 454 and the secondend 462 of the lever arm 454. A biasing force is disposed on the secondend 462 of the lever arm 454 by a spring member 464 that is disposedbetween the second end 462 of the lever arm 454 and a base plate 466.The biasing force in the direction indicated by arrow 468 forces thepenetrating member contact surface 470 of the drive member 442 againstthe outside surface of the penetrating member 446 and, in addition,forces the protuberance 448 of the drive member 442 into the transverseslot 444 of the penetrating member shaft 446.

Referring now to FIG. 49, another embodiment of a replaceable cartridge500 suitable for housing a plurality of individually moveablepenetrating members (not shown) will be described in further detail.Although cartridge 500 is shown with a chamfered outer periphery, itshould also be understood that less chamfered and unchamferedembodiments of the cartridge 500 may also be adapted for use with anyembodiment of the present invention disclosed herein. The penetratingmembers slidably coupled to the cartridge may be a bare lancet or bareelongate member without outer molded part or body pieces as seen inconventional lancet. The bare design reduces cost and simplifiesmanufacturing of penetrating members for use with the present invention.The penetrating members may be retractable and held within the cartridgeso that they are not able to be used again. The cartridge is replaceablewith a new cartridge once all the piercing members have been used. Thelancets or penetrating members may be fully contained in the usedcartridge so at to minimize the chance of patient contact with suchwaste.

As can be seen in FIG. 49, the cartridge 500 may include a plurality ofcavities 501 for housing a penetrating member. In this embodiment, thecavity 501 may have a longitudinal opening 502 associated with thecavity. The cavity 501 may also have a lateral opening 503 allowing thepenetrating member to exit radially outward from the cartridge. As seenin FIG. 49, the outer radial portion of the cavity may be narrowed. Theupper portion of this narrowed area may also be sealed or swaged toclose the top portion 505 and define an enclosed opening 506 as shown inFIG. 50. Optionally, the narrowed area 504 may retain an open topconfiguration, though in some embodiments, the foil over the gap isunbroken, preventing the penetrating member from lifting up or extendingupward out of the cartridge. The narrowed portion 504 may act as abearing and/or guide for the penetrating member. FIG. 51 shows that theopening 506 may have a variety of shapes such as but not limited to,circular, rectangular, triangular, hexagonal, square, or combinations ofany or all of the previous shapes. Openings 507 (shown in phantom) forother microfluidics, capillary tubes, or the like may also beincorporated in the immediate vicinity of the opening 506. In someoptional embodiments, such openings 507 may be configured to surroundthe opening 506 in a concentric or other manner.

Referring now to FIG. 52, the underside of a cartridge 500 will bedescribed in further detail. This figures shows many features on onecartridge 500. It should be understood that a cartridge may includesome, none, or all of these features, but they are shown in FIG. 52 forease of illustration. The underside may include indentations or holes510 close to the inner periphery for purpose of properly positioning thecartridge to engage a penetrating member gripper and/or to allow anadvancing device (shown in FIGS. 56B and 56C) to rotate the cartridge500. Indentations or holes 511 may be formed along various locations onthe underside of cartridge 500 and may assume various shapes such as butnot limited to, circular, rectangular, triangular, hexagonal, square, orcombinations of any or all of the previous shapes. Notches 512 may alsobe formed along the inner surface of the cartridge 500 to assist inalignment and/or rotation of the cartridge. It should be understood ofcourse that some of these features may also be placed on the topside ofthe cartridge in areas not occupied by cavities 501 that house thepenetrating members. Notches 513 may also be incorporated along theouter periphery of the cartridge. These notches 513 may be used togather excess material from the sterility barrier 28 (not shown) thatmay be used to cover the angled portion 514 of the cartridge. In thepresent embodiment, the cartridge has a flat top surface and an angledsurface around the outside. Welding a foil type sterility barrier overthat angled surface, the foil folds because of the change in thesurfaces which is now at 45 degrees. This creates excess material. Thegrooves or notches 513 are there as a location for that excess material.Placing the foil down into those grooves 513 which may tightly stretchthe material across the 45 degree angled surface. Although in thisembodiment the surface is shown to be at 45 degrees, it should beunderstood that other angles may also be used. For example, the surfacemay be at any angle between about 3 degrees to 90 degrees, relative tohorizontal. The surface may be squared off. The surface may beunchamfered. The surface may also be a curved surface or it may becombinations of a variety of angled surfaces, curved and straightssurfaces, or any combination of some or all of the above.

Referring now to FIGS. 53-54, the sequence in which the cartridge 500 isindexed and penetrating members are actuated will now be described. Itshould be understood that some steps described herein may be combined ortaken out of order without departing from the spirit of the invention.These sequence of steps provides vertical and horizontal movement usedwith the present embodiment to load a penetrating member onto thedriver.

As previously discussed, each cavity on the cartridge may beindividually sealed with a foil cover or other sterile enclosurematerial to maintain sterility until or just before the time of use. Inthe present embodiment, penetrating members are released from theirsterile environments just prior to actuation and are loaded onto alauncher mechanism for use. Releasing the penetrating member from thesterile environment prior to launch allows the penetrating member in thepresent embodiment to be actuated without having to pierce any sterileenclosure material which may dull the tip of the penetrating member orplace contaminants on the member as it travels towards a target tissue.A variety of methods may be used accomplish this goal.

FIG. 53A shows one embodiment of penetrating member release device,which in this embodiment is a punch plate 520 that is shown in asee-through depiction for ease of illustration. The punch plate 520 mayinclude a first portion 521 for piercing sterile material covering thelongitudinal opening 502 and a second portion 522 for piercing materialcovering the lateral opening 503. A slot 523 allows the penetratingmember gripper to pass through the punch plate 520 and engage apenetrating member housed in the cartridge 500. The second portion 522of the punch plate down to engage sterility barrier angled at about a 45degree slope. Of course, the slope of the barrier may be varied. Thepunch portion 522 first contacts the rear of the front pocket sterilitybarrier and as it goes down, the cracks runs down each side and thebarrier is pressed down to the bottom of the front cavity. The rear edgeof the barrier first contacted by the punch portion 522 is broken offand the barrier is pressed down, substantially cleared out of the way.These features may be more clearly seen in FIG. 53B. The punch portion521 may include a blade portion down the centerline. As the punch comesdown, that blade may be aligned with the center of the cavity, cuttingthe sterility barrier into two pieces. The wider part of the punch 521then pushes down on the barrier so the they align parallel to the sidesof the cavity. This creates a complete and clear path for the gripperthroughout the longitudinal opening of the cavity. Additionally, as seenin FIGS. 53B and 54A, a plurality of protrusion 524 are positioned toengage a cam (FIG. 55A) which sequences the punching and other verticalmovement of punch plate 520 and cartridge pusher 525. The drive shaft526 from a force generator (not shown) which is used to actuate thepenetrating member 527.

Referring now to FIGS. 54A-F, the release and loading of the penetratingmembers are achieved in the following sequence. FIG. 54A shows therelease and loading mechanism in rest state with a dirty barepenetrating member 527 held in a penetrating member gripper 530. This isthe condition of the device between lancing events. When the time comesfor the patient to initiate another lancing event, the used penetratingmember is cleared and a new penetrating member is loaded, just prior tothe actual lancing event. The patient begins the loading of a newpenetrating member by operating a setting lever to initiate the process.The setting lever may operate mechanically to rotate a cam (see FIG.55A) that moves the punch plate 520 and cartridge pusher 525. In otherembodiments, a stepper motor or other mover such as but not limited to,a pneumatic actuator, hydraulic actuator, or the like are used to drivethe loading sequence.

FIG. 54B shows one embodiment of penetrating member gripper 530 in moredetail. The penetrating member gripper 530 may be in the form of atuning fork with sharp edges along the inside of the legs contacting thepenetrating member. In some embodiments, the penetrating member may benotched, recessed, or otherwise shaped to receive the penetrating membergripper. As the gripper 530 is pushed down on the penetrating member,the legs are spread open elastically to create a frictional grip withthe penetrating member such as but not limited to bare elongate wireswithout attachments molded or otherwise attached thereon. In someembodiments, the penetrating member is made of a homogenous materialwithout any additional attachments that are molded, adhered, glued orotherwise added onto the penetrating member.

In some embodiments, the gripper 530 may cut into the sides of thepenetrating member. The penetrating member in one embodiment may beabout 300 microns wide. The grooves that form in the side of thepenetrating member by the knife edges are on the order of about 5-10microns deep and are quite small. In this particular embodiment, theknife edges allow the apparatus to use a small insertion force to getthe gripper onto the penetrating member, compared to the force to removethe penetrating member from the gripper the longitudinal axis of anelongate penetrating member. Thus, the risk of a penetrating memberbeing detached during actuation are reduced. The gripper 530 may be madeof a variety of materials such as, but not limited to high strengthcarbon steel that is heat treated to increased hardness, ceramic,substrates with diamond coating, composite reinforced plastic,elastomer, polymer, and sintered metals. Additionally, the steel may besurface treated. The gripper 130 may have high gripping force with lowfriction drag on solenoid or other driver.

As seen in FIG. 54C, the sequence begins with punch plate 520 beingpushed down. This results in the opening of the next sterile cavity 532.In some embodiment, this movement of punch plate 520 may also result inthe crimping of the dirty penetrating member to prevent it from beingused again. This crimping may result from a protrusion on the punchplate bending the penetrating member or pushing the penetrating memberinto a groove in the cartridge that hold the penetrating member in placethrough an interference fit. As seen in FIGS. 53B and 54C, the punchplate 520 has a protrusion or punch shaped to penetrate a longitudinalopening 502 and a lateral opening 503 on the cartridge. The firstportion 521 of the punch that opens cavity 532 is shaped to first piercethe sterility barrier and then push, compresses, or otherwise movessterile enclosure material towards the sides of the longitudinal opening502. The second portion 522 of the punch pushes down the sterilitybarrier at lateral opening or penetrating member exit 503 such that thepenetrating member does not pierce any materials when it is actuatedtoward a tissue site.

Referring now to FIG. 54D, the cartridge pusher 525 is engaged by thecam 550 (not shown) and begins to push down on the cartridge 500. Thepunch plate 520 may also travel downward with the cartridge 500 until itis pushed down to it maximum downward position, while the penetratingmember gripper 530 remains vertically stationary. This joint downwardmotion away from the penetrating member gripper 530 will remove thepenetrating member from the gripper. The punch plate 520 essentiallypushes against the penetrating member with protrusion 534 (FIG. 55A),holding the penetrating member with the cartridge, while the cartridge500 and the punch plate 520 is lowered away from the penetrating membergripper 530 which in this embodiment remains vertically stationary. Thiscauses the stripping of the used penetrating member from the gripper 530(FIG. 45D) as the cartridge moves relative to the gripper.

At this point as seen in FIG. 54E, the punch plate 520 retracts upwardand the cartridge 500 is pushed fully down, clear of the gripper 530.Now cleared of obstructions and in a rotatable position, the cartridge500 increments one pocket or cavity in the direction that brings thenewly released, sterile penetrating member in cavity 532 into alignmentwith the penetrating member gripper 530, as see in FIG. 54F. Therotation of the cartridge occurs due to fingers engaging the holes orindentations 533 on the cartridge, as seen in FIG. 54A. In someembodiments, these indentations 533 do not pass completely throughcartridge 500. In other embodiments, these indentations are holespassing completely through. The cartridge has a plurality of littleindentations 533 on the top surface near the center of the cartridge,along the inside diameter. In the one embodiment, the sterility barrieris cut short so as not to cover these plurality of indentations 533. Itshould be understood of course that these holes may be located onbottom, side or other accessible surface. These indentations 533 havetwo purposes. The apparatus may have one or a plurality of locator pins,static pins, or other keying feature that dos not move. In thisembodiment, the cartridge will only set down into positions where thegripper 530 is gripping the penetrating member. To index the cassette,the cartridge is lifted off those pins or other keyed feature, rotatedaround, and dropped onto those pins for the next position. The rotatingdevice is through the use of two fingers: one is a static pawl and theother one is a sliding finger. They engage with the holes 533. Thefingers are driven by a slider that may be automatically actuated oractuated by the user. This maybe occur mechanically or through electricor other powered devices. Halfway through the stroke, a finger mayengage and rotate around the cartridge. A more complete description canbe found with text associated with FIGS. 56B-56C.

Referring now to FIG. 54G, with the sterile penetrating member inalignment, the cartridge 500 is released as indicated by arrows 540 andbrought back into contact with the penetrating member gripper 530. Thenew penetrating member 541 is inserted into the gripper 530, and theapparatus is ready to fire once again. After launch and in betweenlancing events for the present embodiment, the bare lancet orpenetrating member 541 is held in place by gripper 530, preventing thepenetrating member from accidentally protruding or sliding out of thecartridge 500.

It should be understood of course, that variations can be added to theabove embodiment without departing from the spirit of the invention. Forexample, the penetrating member 541 may be placed in a parked positionin the cartridge 500 prior to launch. As seen in FIG. 55A, thepenetrating member is held by a narrowed portion 542 of the cartridge,creating an interference fit which pinches the proximal end of thepenetrating member. Friction from the molding or cartridge holds thepenetrating member during rest, preventing the penetrating member fromsliding back and forth. Of course, other methods of holding thepenetrating member may also be used. As seen in FIG. 55B prior tolaunch, the penetrating member gripper 530 may pull the penetratingmember 541 out of the portion 542. The penetrating member 541 may remainin this portion until actuated by the solenoid or other force generatorcoupled to the penetrating member gripper. A cam surface 544 may be usedto pull the penetrating member out of the portion 542. This mechanicalcam surface may be coupled to the mechanical slider driven by thepatient, which may be considered a separate force generator. Thus,energy from the patient extracts the penetrating member and this reducesthe drain on the device's battery if the solenoid or electric driverwere to pull out the penetrating member. The penetrating member may bemoved forward a small distance (on the order of about 1 mm or less) fromits parked position to pull the penetrating member from the restposition gripper. After penetrating tissue, the penetrating member maybe returned to the cartridge and eventually placed into the parkedposition. This may also occur, though not necessarily, through forceprovided by the patient. In one embodiment, the placing of the lancetinto the parked position does not occur until the process for loading anew penetrating member is initiated by the patient. In otherembodiments, the pulling out of the parked position occurs in the samemotion as the penetrating member actuation. The return into the parkedposition may also be considered a continuous motion.

FIG. 55A also shows one embodiment of the cam and other surfaces used tocoordinate the motion of the punch plate 520. For example, cam 550 inthis embodiment is circular and engages the protrusions 524 on the punchplate 520 and the cartridge pusher 525. FIG. 55A also more clearly showsprotrusion 534 which helps to hold the penetrating member in thecartridge 500 while the penetrating member gripper 530 pulls away fromthe member, relatively speaking. A ratchet surface 552 that rotates withthe cam 550 may be used to prevent the cam from rotating backwards. Theraising and lower of cartridge 500 and punch plate 50 used toload/unload penetrating members may be mechanically actuated by avariety of cam surfaces, springs, or the like as may be determined byone skilled in the art. Some embodiments may also use electrical ormagnetic device to perform the loading, unloading, and release of barepenetrating members. Although the punch plate 520 is shown to bepunching downward to displace, remove, or move the foil or other sterileenvironment enclosure, it should be understood that other methods suchas stripping, pulling, tearing, or some combination of one or more ofthese methods may be used to remove the foil or sterile enclosure. Forexample, in other embodiments, the punch plate 520 may be located on anunderside of the cartridge and punch upward. In other embodiments, thecartridge may remain vertically stationary while other parts such as thepenetrating member gripper and punch plate move to load a sterilepenetrating member on to the penetrating member gripper.

FIG. 55B also shows other features that may be included in the presentapparatus. A fire button 560 may be included for the user to actuate thepenetrating member. A front end interface 561 may be included to allow apatient to seat their finger or other target tissue for lancing. Theinterface 561 may be removable to be cleaned or replaced. A visualdisplay 562 may be included to show device status, lancing performance,error reports, or the like to the patient.

Referring now to FIG. 56A, a mechanical slider 564 used by the patientto load new penetrating member may also be incorporated on the housing.The slider 564 may also be coupled to activate an LCD or visual displayon the lancing apparatus. In addition to providing a source of energy toindex the cartridge, the slider 564 may also switch the electronics tostart the display. The user may use the display to select the depth oflancing or other feature. The display may go back to sleep again untilit is activated again by motion of the slider 564. The underside thehousing 566 may also be hinged or otherwise removable to allow theinsertion of cartridge 500 into the device. The cartridge 500 may beinserted using technology current used for insertion of a compact discor other disc into a compact disc player. In one embodiment, there maybe a tray which is deployed outward to receive or to remove a cartridge.The tray may be withdrawn into the apparatus where it may be elevated,lowered, or otherwise transported into position for use with thepenetrating member driver. In other embodiments, the apparatus may havea slot into which the cartridge is partially inserted at which point amechanical apparatus will assist in completing insertion of thecartridge and load the cartridge into proper position inside theapparatus. Such device is akin to the type of compact disc player foundon automobiles. The insertions/ejection and loading apparatus of thesecompact disc players uses gears, pulleys, cables, trays, and/or otherparts that may be adapted for use with the present invention.

Referring now to FIG. 56B, a more detailed view of one embodiment of theslider 564 is provided. In this embodiment, the slider 564 will moveinitially as indicated by arrow 567. To complete the cycle, the patientwill return the slider to its home position or original startingposition as indicated by arrow 568. The slider 564 has an arm 569 whichmoves with the slider to rotate the cam 550 and engage portions 522. Themotion of the slider 564 is also mechanically coupled to a finger 570which engage the indentations 571 on cartridge 500. The finger 570 issynchronized to rotate the cartridge 500 by pulling as indicated byarrow 572 in the same plane as the cartridge. It should be understoodthat in some embodiments, the finger 570 pushes instead of pulls torotate the cartridge in the correct direction. The finger 570 may alsobe adapted to engage ratchet surfaces 706 as seen in FIG. 66 to rotate acartridge. The finger 570 may also incorporate vertical motion tocoordinate with the rising and lowering of the cartridge 500. The motionof finger 570 may also be powered by electric actuators such as astepper motor or other device useful for achieving motion. FIG. 56B alsoshows a portion of the encoder 573 used in position sensing.

Referring now to FIG. 56C, a still further view of the slider 564 andarm 569 is shown. The arm 569 moves to engage portion 522 as indicatedby arrow 575 and this causes the cam 550 to rotate as indicated by arrow577. In this particular embodiment, the cam 550 rotates about 1/8 of anrotation with each pull of the slider 564. When the slider 564 is returnto its home or start position, the arm 569 rides over the portion 522.The movement of the slider also allows the cam surface 544 to rotateabout pivot point 579. A resilient member 580 may be coupled to the camsurface 544 to cause it to rotate counterclockwise when the arm 569moves in the direction of arrow 567. The pin 580 will remain in contactwith the arm 569. As the cam surface 544 rotates a first surface 582will contact the pin 583 on the gripper block 584 and pull the pin 583back to park a penetrating member into a coupling or narrowed portion542 of the cartridge 500 as seen in FIG. 55A. As the arm 569 is broughtback to the home position, the cam surface 544 rotates back and a secondsurface 586 that rotates clockwise and pushes the penetrating memberforward to be released from the narrowed portion 542 resulting in aposition as seen in FIG. 55B. It should be understood that in someembodiments, the release and/or parking of lancet from portion 542 maybe powered by the driver 588 without using the mechanical assistancefrom cam surface 544.

In another embodiment of the cartridge device, a mechanical feature maybe included on the cartridge so that there is only one way to load itinto the apparatus. For example, in one embodiment holding 50penetrating members, the cartridge may have 51 pockets or cavities. The51^(st) pocket will go into the firing position when the device isloaded, thus providing a location for the gripper to rest in thecartridge without releasing a penetrating member from a sterileenvironment. The gripper 530 in that zeroth position is inside thepocket or cavity and that is the reason why one of the pockets may beempty. Of course, some embodiments may have the gripper 530 positionedto grip a penetrating member as the cartridge 500 is loaded into thedevice, with the patient lancing themselves soon afterwards so that thepenetrating member is not contaminated due to prolonged exposure outsidethe sterile enclosure. That zeroth position may be the start and finishposition. The cartridge may also be notched to engaged a protrusion onthe apparatus, thus also providing a method for allowing the penetratingmember to loaded or unloaded only in one orientation. Essentially, thecartridge 500 may be keyed or slotted in association with the apparatusso that the cartridge 500 can only be inserted or removed at oneorientation. For example as seen in FIG. 56D, the cartridge 592 may havea keyed slot 593 that matches the outline of a protrusion 594 such thatthe cartridge 592 may only be removed upon alignment of the slot 593 andprotrusion 594 upon at the start or end positions. It should beunderstood that other keyed technology may be used and the slot or keymay be located on an outer periphery or other location on the cartridge592 in manner useful for allowing insertion or removal of the cartridgefrom only one or a select number of orientations.

Referring now to FIG. 57, a cross-section of another embodiment of acavity 600 housing a penetrating member is shown. The cavity 600 mayinclude a depression 602 for allowing the gripper 530 to penetratesufficiently deeply into the cavity to frictionally engage thepenetrating member 541. The penetrating member may also be housed in agroove 604 that holds the penetrating member in place prior to and afteractuation. The penetrating member 541 is lifted upward to clear thegroove 604 during actuation and exits through opening 506.

Referring now to FIG. 58, another variation on the system according tothe present invention will now be described. FIG. 58 shows a lancingsystem 610 wherein the penetrating members have their sharpened tippointed radially inward. The finger or other tissue of the patient isinserted through the center hole 611 to be pierced by the member 612.The penetrating member gripper 530 coupled to drive force generator 613operate in substantially the same manner as described in FIGS. 54A-G.The punch portions 521 and 522 operate in substantially the same mannerto release the penetrating members from the sterile enclosures. Thepunch portion 522 may be placed on the inner periphery of the device,where the penetrating member exit is now located, so that sterileenclosure material is cleared out of the path of the penetrating memberexit.

Referring now to FIG. 59, a still further variation on the lancingsystem according to the present invention will now be described. In theembodiments shown in FIGS. 53-54, the penetrating member gripper 530approaches the penetrating member from above and at least a portion ofthe drive system is located in a different plane from that of thecartridge 500. FIG. 59 shows an embodiment where the penetrating memberdriver 620 is in substantially the same plane as the penetrating member622. The coupler 624 engages a bent or L shaped portion 626 of themember 622. The cartridge 628 can rotate to engage a new penetratingmember with the coupler 624 without having to move the cartridge orcoupler vertically. The next penetrating member rotates into position inthe slot provided by the coupler 624. A narrowed portion of thecartridge acts as a penetrating member guide 630 near the distal end ofthe penetrating member to align the penetrating member as it exits thecartridge.

The coupler 624 may come in a variety of configurations. For example,FIG. 60A shows a coupler 632 which can engage a penetrating member 633that does not have a bent or L-shaped portion. A radial cartridgecarrying such a penetrating member 633 may rotate to slide penetratingmember into the groove 634 of the coupler 632. FIG. 60B is a front viewshowing that the coupler 632 may include a tapered portion 636 to guidethe penetrating member 633 into the slot 634. FIG. 60C shows anembodiment of the driver 620 using a coupler 637 having a slot 638 forreceiving a T-shaped penetrating member. The coupler 637 may furtherinclude a protrusion 639 that may be guided in an overhead slot tomaintain alignment of the drive shaft during actuation.

Referring now to FIG. 61, a cartridge 640 for use with an in-planedriver 620 is shown. The cartridge 640 includes an empty slot 642 thatallows the cartridge to be placed in position with the driver 620. Inthis embodiment, the empty slot 642 allows the coupler 644 to bepositioned to engage an unused penetrating member 645 that may berotated into position as shown by arrow 646. As seen in FIG. 61, thecartridge 640 may also be designed so that only the portion of thepenetrating member that needs to remain sterile (i.e. the portions thatmay actually be penetrating into tissue) are enclosed. As seen in FIG.61, a proximal portion 647 of the penetrating member is exposed. Thisexposed proximal portion may be about 70% of the penetrating member. Inother embodiments it may be between about 69% to about 5% of thepenetrating member. The cartridge 640 may further include, but notnecessarily, sealing protrusions 648. These protrusions 648 arereleasably coupled to the cartridge 640 and are removed from thecartridge 640 by remover 649 as the cartridge rotates to placepenetrating member 645 into the position of the active penetratingmember. The sterile environment is broken prior to actuation of themember 645 and the member does not penetrate sterile enclosure materialthat may dull the tip of the penetrating member during actuation. Afracturable seal material 650 may be applied to the member to sealagainst an inner peripheral portion of the cartridge.

Referring now to FIG. 62, a still further embodiment of a cartridge foruse with the present invention will be described. This cartridge 652includes a tapered portion 654 for allowing the coupler 655 to enter thecavity 656. A narrowed portion 657 guides the penetrating member 658.The coupler 655 may have, but does not necessarily have, movable jaws659 that engage to grip the penetrating member 658. Allowing the couplerto enter the cavity 656 allows the alignment of the penetrating memberto be better maintained during actuation. This tapered portion 654 maybe adapted for use with any embodiment of the cartridge disclosedherein.

Referring now to FIG. 63, a linear cartridge 660 for use with thepresent invention will be described. Although the present invention hasbeen shown in use with radial cartridges, the lancing system may beadapted for use with cartridges of other shapes. FIGS. 79-83 show othercartridges of varying shapes adaptable for use with the presentinvention. FIG. 63 illustrates a cartridge 660 with only a portion 662providing sterile protection for the penetrating members. The cartridge660, however, provides a base 664 on which a penetrating member 665 canrest. This provides a level of protection of the penetrating memberduring handling. The base 664 may also be shaped to provide slots 666 inwhich a penetrating member 667 may be held. The slot 666 may also beadapted to have a tapered portion 668. These configurations may beadapted for use with any of the embodiments disclosed herein, such asthe cartridge 652.

Referring now to FIGS. 64A-64C, a variety of different devices are shownfor releasing the sterility seal covering a lateral opening 503 on thecartridge 500. FIG. 64A shows a rotating punch device 670 that hasprotrusions 672 that punch out the sterility barrier creating openings674 from which a penetrating member can exit without touching thesterility barrier material. FIG. 64B shows a vertically rotating device676 with shaped protrusions 678 that punch down the sterility barrier679 as it is rotated to be in the active, firing position. FIG. 64Cshows a punch 680 which is positioned to punch out barrier 682 when thecartridge is lowered onto the punch. The cartridge is rotated and thepunch 680 rotates with the cartridge. After the cartridge is rotated tothe proper position and lifted up, the punch 680 is spring loaded orotherwise configured to return to the position to engage the sterilitybarrier covering the next unused penetrating member.

Referring now to FIG. 65A-65B, another type of punch mechanism for usewith a punch plate 520 will now be described. The device shown in FIGS.53-54 shows a mechanism that first punches and then rotates or indexesthe released penetrating member into position. In this presentembodiment, the cartridge is rotated first and then the gripper andpunch may move down simultaneously. FIG. 65A shows a punch 685 having afirst portion 686 and a second portion 687. As seen in cross-sectionalview of FIG. 65B, the penetrating member gripper 690 is located insidethe punch 685. Thus the penetrating of the sterility barrier isintegrated into the step of engaging the penetrating member with thegripper 690. The punch 685 may include a slot 692 allowing a portion 694of the gripper 690 to extend upward. A lateral opening 695 is providedfrom which a penetrating member may exit. In some embodiments, the punchportion 687 is not included with punch 686, instead relying on someother mechanism such as those shown in FIGS. 64A-64C to press down onbarrier material covering a lateral opening 503.

Referring now to FIGS. 66, a still further embodiment of a cartridgeaccording to the present invention will be described. FIG. 66 shows acartridge 700 with a plurality of cavities 702 and individualdeflectable portions or fingers 704. The ends of the protective cavities702 may be divided into individual fingers (such as one for each cavity)on the outer periphery of the disc. Each finger 704 may be individuallysealed with a foil cover (not shown for ease of illustration) tomaintain sterility until the time of use. Along the inner periphery ofthe cartridge 700 are raised step portions 706 to create a ratchet typemechanism. As seen in FIG. 67, a penetrating member 708 may be housed ineach cavity. The penetrating member may rest on a raised portion 710. Anarrowed portion 712 pinches the proximal portions of the penetrationmember 708. Each cavity may include a wall portion 714 into which thepenetrating member 708 may be driven after the penetrating member hasbeen used. FIG. 68 shows the penetrating member gripper 716 lowered toengage a penetrating member 708. For ease of illustration, a sterilitybarrier covering each of the cavities is not shown.

Referring now to FIGS. 69A-69L, the sequence of steps for actuating apenetrating member in a cartridge 700 will be described. It should beunderstood that in other embodiments, steps may be combined or reducedwithout departing from the sprit of the present invention. The lastpenetrating member to be used may be left in a retracted position,captured by a gripper 716. The end of the protective cavity 704 may bedeflected downward by the previous actuation. The user may operate amechanism such as but not limited to a thumbwheel, lever, crank, slider,etc . . . that advances a new penetrating member 720 into launchposition as seen in FIG. 69A. The mechanism lifts a bar that allows theprotective cavity to return to its original position in the plane of thedisc.

In this embodiment as shown in FIG. 69B, the penetrating member guide722 presses through foil in rear of pocket to “home” penetrating memberand control vertical clearance. For ease of illustration, actuationdevices for moving the penetrating member guide 722 and other mechanismsare not shown. They may be springs, cams, or other devices that canlower and move the components shown in these figures. In someembodiments, the cartridge 700 may be raised or lowered to engage thepenetrating member guide 722 and other devices.

As seen in FIG. 69C, the plough or sterile enclosure release device 724is lowered to engage the cartridge 700. In some embodiments, the disc orcartridge 700 may raised part way upward until a plough or plow blade724 pierces the sterility barrier 726 which may be a foil covering.

Referring now to FIG. 69D, the plough 724 clears foil from front ofpocket and leaves it attached to cartridge 700. The plough 724 is drivenradially inward, cutting open the sterility barrier and rolling thescrap into a coil ahead of the plough. Foil naturally curls over andforms tight coil when plough lead angle is around 55 degs to horizontal.If angle of the plough may be between about 60-40 degs, preferablycloser to 55 degs. In some embodiments, the foil may be removed in sucha manner that the penetrating member does not need to pierce any sterileenclosure materials during launch.

Referring now to FIG. 69E, the gripper 716 may be lowered to engage thebare penetrating member or piercing member 720. Optionally, the disc orcartridge 8000 may be raised until the penetrating member 720 is pressedfirmly into the gripper 716. Although not shown in the present figure,the penetrating member driver or actuator of the present embodiment mayremain in the same horizontal plane as the penetrating member.

As seen in FIG. 69F, a bar 730 may be pressed downward on the outer end732 of the protective cavity to deflect it so it is clear of the path ofthe penetrating member. In the present embodiment, the bar 730 is shapedto allow the bare penetrating member 720 to pass through. It should beunderstood that other shapes and orientations of the bar (such ascontacting only one side or part of end 732) may be used to engage theend 732.

Referring now to FIG. 69G, an electrical solenoid or other electronic orfeed-back controllable drive may actuate the gripper 716 radiallyoutward, carrying the bare penetrating member 720 with it. The barepenetrating member projects from the protective case and into the skinof a finger or other tissue site that has been placed over the apertureof the actuator assembly. Suitable penetrating member drivers aredescribed in commonly assigned, copending U.S. patent application Ser.No. 10/127,395 filed Apr. 19, 2002.

Referring now to FIG. 69H, the solenoid or other suitable penetratingmember driver retracts the bare penetrating member 720 into a retractedposition where it parks until the beginning of the next lancing cycle.

Referring now to FIG. 691, bar 730 may be released so that the end 150returns to an in-plane configuration with the cartridge 800.

As seen in FIG. 69J, the gripper 716 may drive a used bare penetratingmember radially outward until the sharpened tip is embedded into aplastic wall 714 at or near the outward end 732 of the cavity thusimmobilizing the contaminated penetrating member.

As seen in FIGS. 69K and 69L, the plough 724, the gripper 716, andpenetrating member guide 722 may all be disengaged from the barepenetrating member 720. Optionally, it should be understood that theadvance mechanism may lower the cartridge 700 from the gripper 716. Theused penetrating member, restrained by the tip embedded in plastic, andby the cover foil at the opposite end, is stripped from the gripper. Thedisc or cartridge 700 may be rotated until a new, sealed; sterilepenetrating member is in position under the launch mechanism.

Referring now to FIGS. 70 and 71, one object for some embodiments of theinvention is to include blood sampling and sensing on this penetratingmember actuation device. In the present embodiment, the drive mechanism(gripper 738 and solenoid drive coil 739) may be used to drive apenetrating member into the skin and couple this lancing event toacquire the blood sample as it forms at the surface of the finger. In afirst embodiment shown in FIG. 70, microfluidic module 740 bearing theanalyte detecting member chemistry and detection device 742 (FIG. 71) iscouple on to the shaft of the penetrating member 720. The drive cycledescribed above may also actuate the module 740 so that it rests at thesurface of the finger to acquire blood once the penetrating memberretracts from the wound. The module 740 is allowed to remain on thesurface of the finger or other tissue site until the gripper 738 hasreached the back end 744 of the microfluidics module 740, at which pointthe module is also retracted into the casing. The amount of time themodule 740 remains on the finger, in this embodiment, may be variedbased on the distance the end 744 is located and the amount of time ittakes the gripper to engage it on the withdrawal stroke. The bloodfilled module 740, filled while the module remains on pierced tissuesite, may then undergo analyte detection by means such as optical orelectrochemical sensing.

The blood may be filled in the lumen that the penetrating member was inor the module may have separately defined sample chambers to the side ofthe penetrating member lumen. The analyte detecting member may also beplaced right at the immediate vicinity or slightly setback from themodule opening receiving blood so that low blood volumes will stillreach the analyte detecting member. In some embodiments, the analytesensing device and a visual display or other interface may be on boardthe apparatus and thus provide a readout of analyte levels without needto plug apparatus or a test strip into a separate reader device. As seenin FIG. 71, the cover 746 may also be clear to allow for light to passthrough for optical sensing. The analyte detecting member may be usedwith low volumes such as less than about 1 microliter of sample,preferably less than about 0.6 microliter, more preferably less thanabout 0.3 microliter, and most preferably less than about 0.1 microliterof sample.

In another embodiment as seen in FIG. 72, sensing elements 760 may bedirectly printed or formed on the top of bottom of the penetratingmember cartridge 700, depending on orientation. The bare penetratingmember 720 is then actuated through a hole 762 in the plastic facing,withdrawn into the radial cavity followed by the blood sample.Electrochemical or optical detection for analyte sensing may then becarried out (FIG. 72). Again the cavity 766 may have a clear portion toallow light to pass for optical sensing. In one embodiment, amultiplicity of miniaturized analyte detecting member fields may beplaced on the floor of the radial cavity as shown in FIG. 72 or on themicrofluidic module shown in FIG. 71 to allow many tests on a singleanalyte form a single drop of blood to improve accuracy and precision ofmeasurement. Although not limited in this manner, additional analytedetecting member fields or regions may also be included for calibrationor other purposes.

Referring now to FIG. 73, a still further embodiment of a cartridgeaccording to the present invention will be described. FIG. 73 shows oneembodiment of a cartridge 800 which may be removably inserted into anapparatus for driving penetrating members to pierce skin or tissue. Thecartridge 800 has a plurality of penetrating members 802 that may beindividually or otherwise selectively actuated so that the penetratingmembers 802 may extend outward from the cartridge, as indicated by arrow804, to penetrate tissue. In the present embodiment, the cartridge 800may be based on a flat disc with a number of penetrating members suchas, but in no way limited to, (25, 50, 75, 100, . . . ) arrangedradially on the disc or cartridge 800. It should be understood thatalthough the cartridge 800 is shown as a disc or a disc-shaped housing,other shapes or configurations of the cartridge may also work withoutdeparting from the spirit of the present invention of placing aplurality of penetrating members to be engaged, singly or in somecombination, by a penetrating member driver.

Each penetrating member 802 may be contained in a cavity 806 in thecartridge 800 with the penetrating member's sharpened end facingradially outward and may be in the same plane as that of the cartridge.The cavity 806 may be molded, pressed, forged, or otherwise formed inthe cartridge. Although not limited in this manner, the ends of thecavities 806 may be divided into individual fingers (such as one foreach cavity) on the outer periphery of the disc. The particular shape ofeach cavity 806 may be designed to suit the size or shape of thepenetrating member therein or the amount of space desired for placementof the analyte detecting members 808. For example and not limitation,the cavity 806 may have a V-shaped cross-section, a U-shapedcross-section, C-shaped cross-section, a multi-level cross section orthe other cross-sections. The opening 810 through which a penetratingmember 802 may exit to penetrate tissue may also have a variety ofshapes, such as but not limited to, a circular opening, a square orrectangular opening, a U-shaped opening, a narrow opening that onlyallows the penetrating member to pass, an opening with more clearance onthe sides, a slit, a configuration as shown in FIG. 75, or the othershapes.

In this embodiment, after actuation, the penetrating member 802 isreturned into the cartridge and may be held within the cartridge 800 ina manner so that it is not able to be used again. By way of example andnot limitation, a used penetrating member may be returned into thecartridge and held by the launcher in position until the next lancingevent. At the time of the next lancing, the launcher may disengage theused penetrating member with the cartridge 800 turned or indexed to thenext clean penetrating member such that the cavity holding the usedpenetrating member is position so that it is not accessible to the user(i.e. turn away from a penetrating member exit opening). In someembodiments, the tip of a used penetrating member may be driven into aprotective stop that hold the penetrating member in place after use. Thecartridge 800 is replaceable with a new cartridge 800 once all thepenetrating members have been used or at such other time or condition asdeemed desirable by the user.

Referring still to the embodiment in FIG. 73, the cartridge 800 mayprovide sterile environments for penetrating members via seals, foils,covers, polymeric, or similar materials used to seal the cavities andprovide enclosed areas for the penetrating members to rest in. In thepresent embodiment, a foil or seal layer 820 is applied to one surfaceof the cartridge 800. The seal layer 820 may be made of a variety ofmaterials such as a metallic foil or other seal materials and may be ofa tensile strength and other quality that may provide a sealed, sterileenvironment until the seal layer 820 is penetrate by a suitable orpenetrating device providing a preselected or selected amount of forceto open the sealed, sterile environment. Each cavity 806 may beindividually sealed with a layer 820 in a manner such that the openingof one cavity does not interfere with the sterility in an adjacent orother cavity in the cartridge 800. As seen in the embodiment of FIG. 73,the seal layer 820 may be a planar material that is adhered to a topsurface of the cartridge 800.

Depending on the orientation of the cartridge 800 in the penetratingmember driver apparatus, the seal layer 820 may be on the top surface,side surface, bottom surface, or other positioned surface. For ease ofillustration and discussion of the embodiment of FIG. 73, the layer 820is placed on a top surface of the cartridge 800. The cavities 806holding the penetrating members 802 are sealed on by the foil layer 820and thus create the sterile environments for the penetrating members.The foil layer 820 may seal a plurality of cavities 806 or only a selectnumber of cavities as desired.

In a still further feature of FIG. 73, the cartridge 800 may optionallyinclude a plurality of analyte detecting members 808 on a substrate 822which may be attached to a bottom surface of the cartridge 800. Thesubstrate may be made of a material such as, but not limited to, apolymer, a foil, or other material suitable for attaching to a cartridgeand holding the analyte detecting members 808. As seen in FIG. 73, thesubstrate 822 may hold a plurality of analyte detecting members, such asbut not limited to, about 10-50, 50-100, or other combinations ofanalyte detecting members. This facilitates the assembly and integrationof analyte detecting members 808 with cartridge 800. These analytedetecting members 808 may enable an integrated body fluid samplingsystem where the penetrating members 802 create a wound tract in atarget tissue, which expresses body fluid that flows into the cartridgefor analyte detection by at least one of the analyte detecting members808. The substrate 822 may contain any number of analyte detectingmembers 808 suitable for detecting analytes in cartridge having aplurality of cavities 806. In one embodiment, many analyte detectingmembers 808 may be printed onto a single substrate 822 which is thenadhered to the cartridge to facilitate manufacturing and simplifyassembly. The analyte detecting members 808 may be electrochemical innature. The analyte detecting members 808 may further contain enzymes,dyes, or other detectors which react when exposed to the desiredanalyte. Additionally, the analyte detecting members 808 may comprise ofclear optical windows that allow light to pass into the body fluid foranalyte analysis. The number, location, and type of analyte detectingmember 808 may be varied as desired, based in part on the design of thecartridge, number of analytes to be measured, the need for analytedetecting member calibration, and the sensitivity of the analytedetecting members. If the cartridge 800 uses an analyte detecting memberarrangement where the analyte detecting members are on a substrateattached to the bottom of the cartridge, there may be through holes (asshown in FIG. 76), wicking elements, capillary tube or other devices onthe cartridge 800 to allow body fluid to flow from the cartridge to theanalyte detecting members 808 for analysis. In other configurations, theanalyte detecting members 808 may be printed, formed, or otherwiselocated directly in the cavities housing the penetrating members 802 orareas on the cartridge surface that receive blood after lancing.

The use of the seal layer 820 and substrate or analyte detecting memberlayer 822 may facilitate the manufacture of these cartridges 10. Forexample, a single seal layer 820 may be adhered, attached, or otherwisecoupled to the cartridge 800 as indicated by arrows 824 to seal many ofthe cavities 806 at one time. A sheet 822 of analyte detecting membersmay also be adhered, attached, or otherwise coupled to the cartridge 800as indicated by arrows 825 to provide many analyte detecting members onthe cartridge at one time. During manufacturing of one embodiment of thepresent invention, the cartridge 800 may be loaded with penetratingmembers 802, sealed with layer 820 and a temporary layer (not shown) onthe bottom where substrate 822 would later go, to provide a sealedenvironment for the penetrating members. This assembly with thetemporary bottom layer is then taken to be sterilized. Aftersterilization, the assembly is taken to a clean room (or it may alreadybe in a clear room or equivalent environment) where the temporary bottomlayer is removed and the substrate 822 with analyte detecting members iscoupled to the cartridge as shown in FIG. 73. This process allows forthe sterile assembly of the cartridge with the penetrating members 802using processes and/or temperatures that may degrade the accuracy orfunctionality of the analyte detecting members on substrate 822. As anonlimiting example, the entire cartridge 800 may then be placed in afurther sealed container such as a pouch, bag, plastic molded container,etc . . . to facilitate contact, improve ruggedness, and/or allow foreasier handling.

In some embodiments, more than one seal layer 820 may be used to sealthe cavities 806. As examples of some embodiments, multiple layers maybe placed over each cavity 806, half or some selected portion of thecavities may be sealed with one layer with the other half or selectedportion of the cavities sealed with another sheet or layer, differentshaped cavities may use different seal layer, or the like. The seallayer 820 may have different physical properties, such as those coveringthe penetrating members 802 near the end of the cartridge may have adifferent color such as red to indicate to the user (if visuallyinspectable) that the user is down to say 10, 5, or other number ofpenetrating members before the cartridge should be changed out.

Referring now to FIGS. 74 and 75, one embodiment of the microfluidicsused with the analyte detecting members 808 in cartridge 800 will now bedescribed. For ease of illustration, the shape of cavity 806 has beensimplified into a simple wedge shape. It should be understood that moresophisticated configurations such as that shown in FIG. 73 may be used.FIG. 74 shows a channel 826 that assists in drawing body fluid towardsthe analyte detecting members 808. In the present embodiment, twoanalyte detecting members 808 are shown in the cavity 806. This ispurely for illustrative purposes as the cavity 806 may have one analytedetecting member or any other number of analyte detecting members asdesired. Body fluid entering cavity 806, while filling part of thecavity, will also be drawn by capillary action through the groove 826towards the analyte detecting members 808. The analyte detecting members808 may all perform the same analysis, they may each perform differenttypes of analysis, or there may be some combination of the two (somesensors perform same analysis while others perform other analysis).

FIG. 75 shows a perspective view of a cutout of the cavity 806. Thepenetrating member 802 (shown in phantom) is housed in the cavity 806and may extend outward through a penetrating member exit opening 830 asindicated by arrow 832. The position of the tip of penetrating member802 may vary, such as being near the penetrating member exit port orspaced apart from the exit. The location of the tip relative to theanalyte detecting member 808 may also be varied, such as being spacedapart or away from the analyte detecting member or collocated or in theimmediate vicinity of the analyte detecting member. Fluid may then enterthe cavity 806 and directed by channel 826. The channel 826 as shown inFIG. 75 is a groove that is open on top. The channel 826 may be entirelya groove with an open top or it may have a portion that is has a sealedtop forming a lumen, or still further, the groove may be closed exceptfor an opening near the penetrating member exit opening 830. It shouldbe understood that capillary action can be achieved using a groovehaving one surface uncovered. In some embodiments, the analyte detectingmember 808 is positioned close to the penetrating member exit opening830 so that the analyte detecting member 808 may not need a capillarygroove or channel to draw body fluid, such as in FIG. 78.

As seen in FIGS. 75 and 76, the cavity 806 may include the substrate 822coupled to its bottom surface containing the analyte detecting members808. With the analyte detecting members 808 located on the underside ofthe cartridge 800 as seen in the embodiment of FIG. 76, the cartridge800 may include at least one through hole 834 to provide a passage forbody fluid to pass from the cavity 806 to the analyte detecting member808. The size, location, shape, and other features of the through hole834 may be varied based on the cavity 806 and number of analytedetecting members 808 to be provided. In other embodiments, wickingelements or the like may be used to draw body fluid from the groove 826to down to the analyte detecting member 808 via the through hole orholes 834.

Referring now to FIG. 77, a variety of groove and analyte detectingmember configurations are shown on a single cartridge. Theseconfigurations are shown only for illustrative purposes and a singlecartridge may not incorporate each of these configurations. Someembodiments may use any of the detecting members, singly or incombination. It should be understood, however, that analyte detectingmember configuration could be customized for each cavity, such as butnot limited to, using a different number and location of analytedetecting members depending lancing variables associated with thatcavity, such as but not limited to, the time of day of the lancingevent, the type of analyte to be measured, the test site to be lanced,stratum corneum hydration, or other lancing parameter. As a nonlimitingexample, the detecting members may be moved closer towards the outeredge of the disc, more on the side walls, any combination, or the like.

FIG. 77 shows a penetrating member 802 in a cavity 838 with threeanalyte detecting members 808 in the cavity. For ease of illustration,the penetrating member 802 is omitted from the remaining cavities sothat the analyte detecting member configurations can be more easilyseen. Cavity 840 has a channel 826 with two analyte detecting members808. Cavity 842 has a channel 844 coupled to a single analyte detectingmember 808. Cavities 846 and 848 have one and two analyte detectingmembers 808, respectively. The analyte detecting members 808 in thosecavities may be located directly at the penetrating member exit from thecartridge or substantially at the penetrating member exit. Other analytedetecting member configurations are also possible, such as but notlimited to, placing one or more analyte detecting members on a side wallof the cavity, placing the analyte detecting members in particulararrays (for example, a linear array, triangular array, square array,etc.) on the side wall or bottom surface, using mixed types of analytedetecting members (for example, electrochemical and optical, or someother combination), or mixed positioning of analyte detecting members(for example, at least one analyte detecting member on the substratebelow the cartridge and at least one analyte detecting member in thecavity).

FIG. 78 shows an embodiment of cartridge 800 where the analyte detectingmember 850 is located near the distal end of cavity 806. The analytedetecting member 850 may be formed, deposited, or otherwise attachedthere to the cartridge 800. In another embodiment, the analyte detectingmember 850 may be a well or indentation having a bottom with sufficienttransparency to allow an optical analyte detecting member to detectanalytes in fluid deposited in the well or indentation. The well orindentation may also include some analyte reagent that reacts(fluoresces, changes colors, or presents other detectable qualities)when body fluid is placed in the well. In a still further embodiment,analyte detecting member 850 may be replaced with a through hole thatallow fluid to pass there through. An analyte detecting member 808 on asubstrate 822 may be attached to the underside of the cartridge 800,accessing fluid passing from the cavity 806 down to the analytedetecting member 808.

As mentioned above, the analyte detecting members 808 may also be placedright at the immediate vicinity or slightly setback from the moduleopening receiving blood so that low blood volumes will still reach theanalyte detecting member. The analyte detecting members 808 may be usedwith low volumes such as less than about I microliter of sample,preferably less than about 0.6 microliter, more preferably less thanabout 0.3 microliter, and most preferably less than about 0.1.microliter of sample. Analyte detecting members 808 may also bedirectly printed or formed on the bottom of the penetrating membercartridge 800. In one embodiment, a multiplicity of miniaturized analytedetecting member fields may be placed on the floor of the radial cavityor on the microfluidic module to allow many tests on a single analyteform a single drop of blood to improve accuracy and precision ofmeasurement. Although not limited in this manner, additional analytedetecting member fields or regions may also be included for calibrationor other purposes.

Referring now to FIGS. 79-84, further embodiments of the cartridge 800will now be described. FIG. 79 shows a cartridge 860 having ahalf-circular shape. FIG. 80 shows a cartridge 862 in the shape of apartial curve. FIG. 80 also shows that the cartridges 862 may be stackedin various configurations such as vertically, horizontally, or in otherorientations. FIG. 81 shows a cartridge 864 having a substantiallystraight, linear configuration. FIG. 82 shows a plurality of cartridges864 arranged to extend radially outward from a center 866. Eachcartridge may be on a slide (not shown for simplicity) that allows thecartridge 864 to slide radially outward to be aligned with a penetratingmember launcher. After use, the cartridge 864 is slide back towards thecenter 866 and the entire assembly is rotated as indicated by arrow 868to bring a new cartridge 864 into position for use with a penetratingmember driver. FIG. 83 shows a still further embodiment where aplurality of cartridges 800 may be stacked for use with a penetratingmember driver (see FIG. 85). The driver may be moved to align itselfwith each cartridge 800 or the cartridges may be moved to alightthemselves with the driver. FIG. 84 shows a still further embodimentwhere a plurality of cartridge 864 are coupled together with a flexiblesupport to define an array. A roller 870 may be used to move thecartridges 864 into position to be actuated by the penetrating memberdriver 872.

Referring now to FIG. 85, one embodiment of an apparatus 880 using aradial cartridge 800 with a penetrating member driver 882 is shown. Acontoured surface 884 is located near a penetrating member exit port886, allowing for a patient to place their finger in position forlancing. Although not shown, the apparatus 880 may include a humanreadable or other type of visual display to relay status to the user.The display may also show measured analyte levels or other measurementor feedback to the user without the need to plug apparatus 880 or aseparate test strip into a separate analyte reader device. The apparatus880 may include a processor or other logic for actuating the penetratingmember or for measuring the analyte levels. The cartridge 800 may beloaded into the apparatus 880 by opening a top housing of the apparatuswhich may be hinged or removably coupled to a bottom housing. Thecartridge 800 may also drawn into the apparatus 880 using a loadingmechanism similar in spirit to that found on a compact disc player orthe like. In such an embodiment, the apparatus may have a slot (similarto a CD player in an automobile) that allows for the insertion of thecartridge 800 into the apparatus 880 which is then automatically loadedinto position or otherwise seated in the apparatus for operationtherein. The loading mechanism may be mechanically powered orelectrically powered. In some embodiments, the loading mechanism may usea loading tray in addition to the slot. The slot may be placed higher onthe housing so that the cartridge 800 will have enough clearance to beloaded into the device and then dropped down over the penetrating memberdriver 882. The cartridge 800 may have an indicator mark or indexingdevice that allows the cartridge to be properly aligned by the loadingmechanism or an aligning mechanism once the cartridge 800 is placed intothe apparatus 880. The cartridge 800 may rest on a radial platform thatrotates about the penetrating member driver 882, thus providing a methodfor advancing the cartridge to bring unused penetrating members toengagement with the penetrating member driver. The cartridge 800 on itsunderside or other surface, may shaped or contoured such as withnotches, grooves, tractor holes, optical markers, or the like tofacilitate handling and/or indexing of the cartridge. These shapes orsurfaces may also be varied so as to indicate that the cartridge isalmost out of unused penetrating members, that there are only fivepenetrating members left, or some other cartridge status indicator asdesired.

A suitable method and apparatus for loading penetrating members has beendescribed previously in commonly assigned, copending U.S. patentapplications and are included here by reference for all purposes.Suitable devices for engaging the penetrating members and for removingprotective materials associated with the penetrating member cavity aredescribed in commonly assigned, copending U.S. patent applications Ser.Nos. 60/422,988 and 60/424,429, and are included here by reference forall purposes. For example in the embodiment of FIG. 78, the foil or seallayer 820 may cover the cavity by extending across the cavity along atop surface 890 and down along the angled surface 892 to provide asealed, sterile environment for the penetrating member and analytedetecting members therein. A piercing element described in U.S. patentapplications Ser. Nos. 60/424,429 has a piercing element and then ashaped portion behind the element which pushes the foil to the sides ofthe cavity or other position so that the penetrating member 802 may beactuated and body fluid may flow into the cavity.

Referring now to FIG. 86, a still further embodiment of a lancing systemaccording to the present invention will be described. A radial cartridge500 may be incorporated for use with a penetrating member driver 882. Apenetrating member may be driven outward as indicated by arrow 894. Aplurality of analyte detecting members are presented on a roll 895 thatis laid out near a penetrating member exit. The roll 895 may be advancedas indicated by arrow 896 so that used analyte detecting members aremoved away from the active site. The roll 895 may also be replaced by adisc holding a plurality of analyte detecting members, wherein theanalyte detecting member disc (not shown) is oriented in a planesubstantially orthogonal to the plane of cartridge 500. The analytedetecting member disc may also be at other angles not parallel to theplane of cartridge 500 so as to be able to rotate and present new,unused analyte detecting member in sequence with new unused penetratingmembers of cartridge 500.

Referring now to FIG. 87A, the cartridge 500 provides a high densitypackaging system for a lancing system. This form factor allows a patientto load a large number penetrating members through a single cartridgewhile maintaining a substantially handheld device. Of course such acartridge 500 may also be used in non-handheld devices. The presentcartridge 500 provide a high test density per volume of the disposable.For embodiments of a cartridge that includes analyte detecting membersin addition to penetrating members such as cartridge 800, the densitymay also be measured in terms of density of analyte detecting membersand penetrating members in a disposable. In other embodiments, thedensity may also be expressed in terms of analyte detecting members perdisposable. For example, by taking the physical volume of one embodimentor the total envelope, this number can be divided by the number ofpenetrating members or number of tests. This result is the volume perpenetrating member or per test in a cassetted fashion. For example, inone embodiment of the present invention, the total volume of thecartridge 500 is determined to be 4.53 cubic centimeters. In this oneembodiment, the cartridge 500 holds 50 penetrating members. Dividing thevolume by 50, the volume per test is arrived at 0.090 cubic centimeters.Conventional test devices such as drum is in the range of 0.720 or 0.670cubic centimeters and that is simply the volume to hold a plurality oftest strips. This does not include penetrating members as does thepresent embodiment 800. Thus, the present embodiment is at asubstantially higher density. Even a slightly lower density devicehaving penetrating members and analyte detecting members in the 0.500cubic centimeter range would be a vast improvement over known devicessince the numbers listed above for known devices does not includepenetrating members, only packaging per test strip.

Each penetrating member (or penetrating member and analyte detectingmember, as the case may be ) may have a packing density, or occupiedvolume, in cartridge 500. In various embodiments, the packing density oroccupied volume of each penetrating member in cartridge 500 may be nomore than about 0.66 cm3, 0.05 cm3, 0.4 cm3, 0.3 cm3, 0.2 cm3, 0.1 cm3,0.075 cm3, 0.05 cm3, 0.025 cm3, 0.01 cm3, 0.090 cm3, 0.080 cm3, and thelike. These numbers applicable to volumes for penetrating members alone,or for combined penetrating members and analyte detecting members. Inother words, the volume required for each penetrating member does notexceed 0.66 cm3/penetrating member, 0.05 cm3/penetrating member, 0.4cm3/penetrating member, 0.3 cm3/penetrating member, 0.2 cm3/penetratingmember, 0.1 cm3/penetrating member, 0.075 cm3/penetrating member, 0.05cm3/penetrating member, 0.025 cm3/penetrating member, 0.01cm3/penetrating member, 0.090 cm3/penetrating member and the like. So,if the total package volume of the cartridge is defined as X and thecartridge includes Y number of penetrating members, penetrating membersand test area, or other unit 395, the volume for each unit does notexceed 0.66 cm3, 0.05 cm3, 0.4 cm3, 0.3 cm3, 0.2 cm3, 0.1 cm3, 0.075cm3, 0.05 cm3, 0.025 cm3, 0.01 cm3, 0.090 cm3, 0.080 cm3, and the like.

Referring now to FIG. 87B, a still further embodiment of a cartridgeaccording to the present invention will now be described. FIG. 87B showsa cross-section of a conical shaped cartridge with the penetratingmember being oriented in one embodiment to move radially outward asindicated by arrow 897. In another embodiment, the penetrating membermay be oriented to move radially inward as indicated by arrow 895. Thegripper may be positioned to engage the penetrating member from an innersurface or an outer surface of the cartridge.

Referring now to FIG. 88, nanowires may also be used to create lowvolume analyte detecting members used with the cartridge 800. Furtherdetails of a nanowire device is described in commonly assigned,copending U.S. Provisional Patent Application Ser. No. 60/433,286 filedDec. 13, 2002, fully incorporated herein by reference for all purposes.These nanowire analyte detecting members 898 may be incorporated intothe cavity 806 housing the penetrating member 802. They may be placed onthe floor or bottom surface of the cavity 806, on the wall, on the topsurface, or any combinations of some or all of these possibilities. Theanalyte detecting members 898 may be designed to have differentsensitivity ranges so as to enhance the overall sensitivity of an arrayof such analyte detecting members. Methods to achieve this may include,but are not limited to, using nanowires of varying sizes, varying thenumber of nanowires, or varying the amount of glucose oxidase or otherglucose detection material on the nanowires. These nanowire analytedetecting members may be designed to use low volumes of body fluid foreach sample, due to their size. In some embodiments, each of the analytedetecting members are accurate using volumes of body fluid sample lessthan about 500 nanoliters. In some embodiments, each of the analytedetecting members are accurate using volumes of body fluid sample lessthan about 300 nanoliters. In still other embodiments, each analytedetecting member is accurate with less than about 50 nanoliters, lessthan about 30 nanoliters, less than about 10 nanoliters, less than about5 nanoliters, and less than about 1 nanoliters of body fluid sample. Insome embodiments, the combined array of analyte detecting members usesless than 300 nanoliters of body fluid to arrive at an analytemeasurement.

Referring now to FIG. 89, a still further embodiment of the presentinvention will be described. FIG. 89 shows one embodiment of an opticalillumination system 910 for use with optical analyte detecting members(FIG. 91) that may be in contact with a body fluid sample. The overallsystem may include a plurality of analyte detecting members whichprovide some optical indicator, a light source 912 for providing lightto shine on the analyte detecting members, at least one light detector914, and a processor (not shown). The analyte detecting member oranalyte detecting members are exposed to a sample of the fluid ofunknown composition. A plurality of analyte detecting members may bearranged into an array of analyte detecting members exposed to one fluidsample, each group targeting a specific analyte and may contain ananalyte-specific chemical that interacts more specifically with oneanalyte than with some other analytes to be analyzed. Each analytedetecting member may also have different sensitivity ranges so as tomaximize overall sensitivity of an array of such analyte detectingmembers. The light source 912 shines light on at least one analytedetecting member to cause light interaction. The differences in theanalyte detecting members may lead to differences in the lightinteraction. The light detector detects the light interaction by theanalyte detecting members. The processor analyzes the light interactionby the analyte detecting members to take into account interference inlight interaction among the analytes, thereby determining theconcentration of the desired analyte in the fluid.

Referring still to the embodiment of FIG. 89, the light source 912 maybe but is not limited to an LED. An alternative LED 915 may also be usedwith the present invention. Light, illumination, or excitation energyfrom LED 912 travels along a path through a pinhole 916, a filter 917,and a lens 918. The light then comes into contact with a beamsplitter919 such as a dichroic mirror or other device useful for beamsplitting.The light is then directed towards lens 920 as indicated by arrow 921.The lens 920 focuses light onto the analyte detecting member (FIG. 91).This excitation energy may cause a detectable optical indicator from theanalyte detecting member. By way of example and not limitation,fluorescence energy may be reflected bay up the lens 920. This energypasses through the beamsplitter 919 and to lens 922 which is thenreceived by detector 914 as indicated by arrow 923. The detector 914measures the energy and this information is passed on to the processor(not shown) to determine analyte levels. The illumination system 910 mayalso include cells 924 on the disc surface. In this specific embodiment,a penetrating member 925 drive by a force generator 926 such as but notlimited to a solenoid may be used to obtain the fluid sample. A detent927 may also be included with the device along with other bare lancetsor penetrating members 928.

Referring now to FIG. 90, another embodiment of the illumination system910 is shown for use with a cartridge 929. Cartridge 929 is similar tocartridge 800. Cartridge 929 is a single cartridge having a plurality ofpenetrating members and a plurality of optical analyte detecting members(not shown). The cartridge 929 further includes a plurality of opticallytransparent portions 930 which may be but is not limited to windows orthe like for the light from LED 912 to shine into a cavity of thecartridge 929. In one embodiment, each cavity of the cartridge 929 mayinclude at least one transparent portion 930. This allows the light togenerate energy that may be read by analyte detecting member 914. Thecartridge 929 may be used a driver 882 to actuate penetrating membersand the cartridge 929 may rotate as indicated by arrow 931.

Referring now to FIG. 91, a cross-section of a similar embodiment of theillumination system is shown. This system 932 has source 912 with a lens933 having an excitation filter 934. This excitation filter 934, in oneembodiment, only allows excitation energy to pass. This filter 934allows the excitation energy to pass to dichroic mirror 935, but doesnot let it return to source 912. Excitation energy is reflected down asindicated by arrow 936. Lens 937 focuses the energy to optical analytedetecting member 938. Fluorescence energy 939 passes through thedichroic mirror 935 and towards a fluorescent filter 940. In oneembodiment, the fluorescent filter 940 only allows fluorescent energy topass through to lens 941. Thus, the detector 914 only receivesfluorescent energy from the analyte detecting member 938. It should beunderstood of course, that the filter may be changed to allow the typeof energy being generated by analyte detecting member 938 to pass. Insome embodiments, no filter may be used. The dichroic mirror 935 may bea Bk7 substrate, 63×40×8 mm. The filters may also be a Bk7 substrateabout 40 mm in diameter and about 6 mm thick. The lens 933, 937, and 941may be achormat:bfl=53.6, working aperture 38 mm.

Referring now to FIG. 92, a still further embodiment of an illuminationsystem 942 will be described. This system does not use a beamsplitter ordichroic mirror. Instead, both the source or LED 912 and detector 914have direct line of sight to the optical analyte detecting member 938.In this embodiment, multiple elements are combined into a singlehousing. For example, lens 943, lens 944, and filter 945 are combinedwhile lens 946, lens 947, and filter 948 are also combined.

Referring now to FIG. 93, a cross-section of a system similar to that ofFIG. 89 is shown in a housing 950. LED 912 sends light to mirror 919 toa light path 951 to cells 924 on a surface of the disc. A finger access952 allows a sample to be obtained and flow along a fluid pathway 953 tobe analyzed. A processor 954 may be coupled to detector 914 to analyzethe results.

Referring now to FIG. 94, a cross-section of a system similar to that ofFIG. 90 will be further described. This shows a cartridge 929 used witha driver 882. This allows for a radial design where the penetratingmembers extend radially outward as indicated by arrow 955. The driver882 may have a coupler portion that reciprocates as indicated by arrow956. FIGS. 95 and 96 provide further views of a system similar to thatof FIG. 89. The embodiment of FIGS. 95 and 96 may include additionallenses or filters as may be useful to refine energy detection.

Referring now to FIG. 97, the area of interest is the velocity profile1000 while the lancet is cutting through the skin layers in the fingeruntil it reaches a predetermined depth. More specifically, variation oflancet velocity through different phases of the inbound trajectory isshown in FIG. 97. In this embodiment, Phase I corresponds to the stratumcorneum, phase II to the epidermis and phase III to the dermis. At eachphase (and during the phase), the options are to maintain currentvelocity, increase current velocity or decrease current velocity. Basedon the thickness of the stratum corneum, velocity could be monitored andchanged in this embodiment at 9 points in the stratum corneum, 6 pointsin the epidermis, and 29 points in the dermis using the four edgedetection algorithm and the 360 strips per inch encoder strip. It shouldbe noted that although the embodiment of the driver discussed hereinproduces the previously discussed number of monitoring points for agiven displacement, other driver and position sensor embodiments may beused that would give higher or lower resolution.

For the purposes of the present discussion for this nonlimiting example,the skin is viewed as having three distinct regions or tissue layers:the stratum corneum SC (Phase I), the epidermis E (Phase II) and thedermis D (Phase III). In one embodiment, the lancet or penetratingmember 10 is accelerated to a first desired velocity. This velocity maybe predetermined or it may be calculated by the processor duringactuation. The processor is also used to control the lancet velocity intissue. At this velocity, the lancet 10 will impact the skin andinitiate cutting through the stratum corneum. The stratum corneum ishard, hence in this embodiment, maximum velocity of the penetratingmember 10 may be employed to efficiently cut through this layer, andthis velocity may be maintained constant until the lancet passes throughthe layer. Power will likely need to be applied to the lancet drive 12while the lancet is cutting through the stratum corneum in order tomaintain the first velocity. Average stratum corneum thickness is about225 μm. Using a four-edge detection algorithm for the position sensor 14of this embodiment, the opportunity to verify and feed back velocityinformation can be carried out at 225/17 or roughly 13 points. Inanother embodiment accelerating through the stratum corneum followingimpact may improve cutting efficiency. Acceleration may be possible ifthe lancet has not reached its target or desired velocity before impact.FIG. 4 shows the result of increasing ((a) arrows, maintaining ((b)arrows) or reducing ((c) arrows) velocity on the lancet trajectory foreach of the tissue layers.

On reaching the epidermis E (Phase II), an embodiment of a method maydecrease the velocity ((c) arrows) from the first velocity so thattissue compression is reduced in this second tissue layer. Thus thelancet 10, in this nonlimiting example, may have a second desiredvelocity that is less than the first velocity. The reduced speed in thesecond tissue layer may reduce the pain experienced by the mechanoreceptor nerve cells in the dermal layer (third tissue layer). In theabsence of tissue compression effects on the dermal layer, however,lancet velocity may be kept constant for efficient cutting (i.e. secondvelocity may be maintained the same as the first velocity). In anotherembodiment, velocity may be increased in the second tissue layer fromthe first velocity.

In Phase III, the lancet or penetrating member 10 may reach the bloodvessels and cut them to yield blood. The innervation of this thirdtissue layer and hence pain perception during lancing could be easilyaffected by the velocity profile chosen. In one embodiment, a thirddesired velocity may be chosen. The velocity may be chosen to minimizenerve stimulation while maintaining cutting efficiency. One embodimentwould involve reducing velocity from the second velocity to minimizepain, and may increase it just before the blood vessels to be cut. Thenumber of velocity measurement steps possible for the position sensordescribed above in the dermis is approximately 58. The user woulddetermine the best velocity/cutting profile by usage. The profile withthe least amount of pain on lancing, yielding a successful blood samplewould be programmable into the device.

Currently users optimize depth settings on mechanical launchers bytesting various settings and through usage, settle on a desired settingbased on lancing comfort. Embodiments of the device and methodsdiscussed herein provide a variety of velocity profiles (FIG. 97), whichcan be optimized by the user for controlled lancing, and may include:controlling the culling speed of a lancet with the lancet within theskin; adjusting the velocity profile of the lancet while the lancet isin the skin based upon the composition of the skin layers; lancingaccording to precise regional velocity profiles based on variation incell type from the surface of the skin down through the epidermis anddennis; lancing at a desired velocity through any tissue layer andvarying the velocity for each layer. This may include maximum velocitythrough the stratum corneum, mediation of velocity through epidermis tominimize shock waves to pain sensors in dermis, and mediation ofvelocity through dermis for efficient cutting of blood vessels withoutstimulating pain receptors. Additional details may be found in commonlyassigned, co-pending U.S. patent application Ser. No. 10/420,535 filedApr. 21, 2003, included herein by reference.

If the distance of the penetrating member tip from the target tissue isknown, acceleration and displacement of the lancet is known and thestart position of the penetrating member is know, the time and positionof tissue contact and depth of penetration can be determined by theprocessor.

The position sensor can accurately measure the distance from theinitialization point to the point of contact, where the resistance toadvancement of the penetrating member stops the penetrating membermovement. The penetrating member is then retracted to the initializationpoint having measured the distance to the target tissue without creatingany discomfort to the user.

Referring now to FIG. 98, another embodiment of the present inventionwill now be described. Some embodiments of the present invention mayprovide an accurate method to locate the point on the body where thesample will be taken. As a nonlimiting example, a beam of light may beused. Additionally, the beam may be used to indicate readiness tosample. In a still further embodiment, the reflected light beam may beused to arm the device for use or to actually activate the device.

As seen in the embodiment of FIG. 98, a light source 1000 may be used toproject a light beam on to the surface of the skin or tissue. A varietyof light sources may be used. The light source include but are notlimited to an incandescent, light emitting diode, fluorescent,electroluminescent or other type of light sources. The light source1000, in most embodiments, emits radiation in the spectrum visible tothe human eye. The light source 1000 may also emit radiation at otherwavelengths such as but not limited to ultraviolet, infrared, or thelike and would be detected by a separate detector device. One examplemay be similar to the device of FIG. 99. Although the embodiment of FIG.98 uses a plurality of light sources 1000, it should be understood thatsome embodiments may only use a single light source 1000.

In the embodiment of FIG. 98, an element may be provided to guide thelight to the target area of the body. This may be accomplished by usinga light source with a built in collimating means such as a lens. Anotherway to guide the light is to allow it to escape through one or moreapertures 1002 in the device. An end cap or front end 103 may beprovided to facilitate finger positioning. A still further way is to usea form of fiber optics or light pipe technology that makes a beam oflight on the body. The light pipe technology may have lenses (such as,but not limited to, conventional or Fresnel) built into them. As seen inFIG. 98, the lancet or penetrating member 1004 exits through an opening1006. The device may include a coupler 1008 attaching a driver to thepenetrating member 1004. Wires or leads 110 may be used to deliver powerto drive the light source 1000. It should be understood that the numberof light beams may vary. The light beams may be one, two, or moreindividual beams or a continuous ring or other shape of light (such asbut limited to a circle, a dot, an X, an icon, an logo, etc . . . ) tomark the point of impact. The light source 1000 may also projectdifferent color of light. As a nonlimiting example, a first color oflight may be used for targeting, and a second color of light when thedevice is aimed correct or at a desired target. For example, a red lightmay be used initially and a green light when the device is accuratelytargeted. Two different light sources 1000 may be used to provide thedifferent colors of light.

Referring now to FIG. 99, an additional feature could allow a photodiode or similar sensor 1020 to detect the reflected light from thesource 1000, which may be used for a variety of purposes such as armingthe device for actuation, determining skin characteristics, or using thereflected signal to initiate the lancing operation. In the embodiment ofFIG. 99, fiber optics 1022 may be used to carry light from the source1000 for projection. In one embodiment, the light beam may be modulatedat a fairly high frequency that may enhance the detection process, bydetecting an AC coupled detector signal. The reflection of the locationlight beam may be used to detect proximity of the anatomical feature.Modulation provides one method to reject ambient light levels that wouldfalsely indicate proximity of the anatomical feature. The light isprojected to a point of sampling S, where the lancet or penetrating ifactuated, will create a wound.

There are additional uses for the light source 1000—the light may beused with an electronic actuator to indicate that the device is ready tolance. In addition to the beam illuminating the site of lancing, thelight could be visible within the body of the device as an easy to seeready to use signal. In this case a switch would turn on and off thelight source to indicate the status of the device. In anotherembodiment, a visual indicator 1040 on the device may light up or changecolor when the device is properly aimed. An indicator, change of image,flashing of black and white on an LCD display screen on the device mayalso be used to indicate proper aim. In some situations, when the deviceis aimed over a ridge on the finger (i.e. ridge associated with lines ona finger that creates fingerprints), the light may indicate one colorand a second color when the device aimed over a valley or trough betweenridges. In some embodiments, a second light beam or second image isprojected when the device is aimed as desired. The beam of light may becontrolled to indicate readiness for service to the operator.Additionally, the beam may be made visible by a secondary lightconduction path (other than the light beam).

Referring now to FIG. 100, in this embodiment, it is shown the lightsource 1000 does not need to be located in front of the cartridge 500.It should be understood that the light source 100 may have anoverlapping configuration where the source may be above, below, or tothe side of the cartridge. The light source 1000 may be used with adevice that only contains one penetrating member 1004 or a device thatcontains multiple penetrating members. In some embodiments which use alight source 912 for analyte detection or measurement, the light source912 may also be used to provide a light for aiming purposes via anoptical train 1042 such as but not limited to optical fiber, mirrors, orlens. For ease of illustration, the other optical components used forlight source 912 to perform its analyte measurement functions are notshown in FIG. 100.

Referring now to the embodiments in FIGS. 100 and 101, a portion 1050 ofthe housing 1052 may be transparent to facilitate viewing of the fingeras it is positioned to be lanced. The embodiment in FIG. 101 provides asubstantially larger area to be clear while the embodiment in FIG. 102provides a clear area in a round, circular, square, rectangular,polygonal, other shaped window near the lancing location. It should beunderstood that any of the light beam embodiments, clear housingembodiments, and other features used for aiming may be combined with anyof the embodiments disclosed herein or with embodiments in referencesenclosed herein by reference.

Referring now to FIG. 103, a still further embodiment of the presentinvention will now be described. FIG. 103 is an exploded view showing acartridge 1100, a layer 1102 with a plurality of analyte detectingmember 1104, and a sterility barrier 1106. The analyte detecting members1104 on layer 1102 may have leads or connectors 1108 that extend alongthe layer 1102. In some embodiments, these leads 1108 extend all the wayto the inner circumference of the layer 1102. In other embodiments, theleads 1108 may not extend all the way to the inner circumference. Asindicated by arrows 1110 and 1112, the layer 1102 and sterility barrier1106 may be coupled to the cartridge 1100 to form a device for use witha lancing apparatus 880. In most embodiments, penetrating members (notshown) are contained in the cartridge 1100 prior to coupling thesterility barrier 1106 to the cartridge 1100.

Referring now to the embodiment of FIG. 104, a cartridge 1114 is shownwherein cavities 1116 are of extended length and have a penetratingmember grip or park area 1118. This area 1118 holds the penetratingmember (not shown) in place prior to actuation. It may also be used tohold the penetrating member in place after actuation. The cartridge 1114may also have notches 1120 formed along the inner circumference of thecartridge. These notches 1120 may be used for positioning purposes, forpurposes of rotating the cartridge, or any combination of the two orother reasons. For non-circular configurations, the notches 1120 areformed along the walls of an opening through the noncircular cartridge.

FIG. 105 is an enlarged view of a portion of the cartridge 1114. Alongthe outer periphery of the cartridge 1114, a chamber 1122 is formed. Inone embodiment, blood or other body fluid from a wound created by thelancing will gather in the chamber 1122. A channel 1124 may be presentto draw fluid towards an opening 1126. In one embodiment, an analytedetecting member (not shown) may occupy the opening 1126. In someembodiments, the analyte detecting member forms the bottom wall of theopening 1126, instead of occupying the opening 1126. In someembodiments, there are no fluid bearing structures on the underside ofthe cartridge 1114.

Referring now to the embodiments of FIGS. 106 and 107, configurationsfor the underside of the cartridge 1114 are shown. In this embodiment,opening 1126 leads to a fluid channel 1128 on the underside of thecartridge 1114. The channel 1128 may be selected of a length sufficientto contain a volume of blood sufficient to substantially fill theexpanded fluid area 1130. As a nonlimiting example, the channel 1128 maybe configured to hold at least about 1.5 μl, 1.4 μl, 1.3 μl, 1.2 μl, 1.1μl, 1.0 μl, 0.9 μl, 0.8 μl, 0.7 μl, 0.6 μl, 0.5 μl, 0.4 μl, 0.3 μl, 0.2μl, 0.1 μl, 0.05 μl, or 0.01 μl. As another nonlimiting example, thechannel 1128 may also be viewed as holding no more than about 1.5 μl,1.4 μl, 1.3 μl, 1.2 μl, 1.1 μl, 1.0 μl, 0.9 μl, 0.8 μl, 0.7 μl, 0.6 μl,0.5 μl, 0.4 μl, 0.3 μl, 0.2 μl, 0.1 μl, 0.05 μl, or 0.01 μl, prior tothe fluid entering the area 1130. In a still further embodiment, theamount of fluid flowing from the channel 1128 into the area 1130 willnot exceed about 1.5 μl, 1.4 μl, 1.3 μl, 1.2 μl, 1.1 μl, 1.0 μl, 0.9 μl,0.8 μl, 0.7 μl, 0.6 μl, 0.5 μl, 0.4 μl, 0.3 μl, 0.2 μl, 0.1 μl, 0.05 μl,or 0.01 μl, depending on the amount desired by the various detectingmembers. The analyte detecting member (not shown), in one embodiment,will occupy or will correspond in location to the area 1130. When fluidfills the fluid channel 1128 and enters the area 1130, the suddenexpansion of width will cause fluid to rush into the area 1130,preferably in a volume sufficient to substantially fill the area or atleast in sufficient volume for an analyte detecting member to make areading. The area 1130 may hold about 1.5 μl, 1.4 μl, 1.3 μl, 1.2 μl,1.1 μl, 1.0 μl, 0.9 μl, 0.8 μl, 0.7 μl, 0.6 μl, 0.5 μl, 0.4 μl, 0.3 μl,0.2 μl, 0.1 μl, 0.05 μl, or 0.01 μl. In some embodiments, the area 1130is designed to hold a volume slightly less than the amount of that canbe held in the channel 1128 prior to the fluid reaching the area 1130.In one nonlimiting example, this may be about 0.01 μl, 0.05 μl, or 0.1μl less. A vent 1132 may be fluidly coupled to the expanded fluid area1130 to handle any overflow of fluid. The vent 1132 reconnects to thecavity 1116 on the other side of the cartridge.

FIGS. 108 and 109 show a still further embodiment according to thepresent invention. FIG. 108 shows an embodiment where the opening 1134is moved even closer to the outer periphery of the chamber 1122. Again,in some embodiments, the cartridge 1114 may not have any fluid bearingchannels or structures. An analyte detecting member may occupy theopening 1134, form the underside of the opening 1134, or somecombination of the two. FIG. 108 also shows a groove 1136 for gatheringexcess material from a sterility barrier 1106. FIG. 109 shows anembodiment where the opening 1134 opens directly into expanded area1138. There is no channel to bring the fluid to the expanded area 1138.In this embodiment, three analyte detecting members 1140, 1142, and 1144may be associated with each area 1138. In any of the embodiments of thepresent invention, it should be understood that a single or a pluralityof analyte detecting members may be associated with each area, such asarea 1138. In any of the embodiments of the present invention, it shouldbe understood that the analyte detecting members may be performing thesame analysis, different analysis, or any combination thereof.

Referring now to the embodiment of FIG. 110, a rib 1146 is positionedacross the opening 1148 in the chamber 1150. The chamber 1150 ispositioned to receive body fluid from a wound created by the lancingevent. The rib 1146 may be formed from a variety of materials such as,but not limited to, a cyclic olefin or other plastic well known in theart. In some embodiments, it can be made hydrophilic by surfacetreatments or the surrounding area can be made hydrophobic. In oneembodiment, the rib 1146 may be made very thin, on the order of about100 microns. The rib 1146 may also have other thicknesses such as lessthan about 200 microns or less than about 300 microns. It should beunderstood that in one embodiment, the rib 1146 may be integrally formedwith the cartridge or it may be attached or coupled to the cartridgeafter the cartridge is formed. An analyte detecting member may occupythe opening 1148, forms the underside of the opening 1148, or somecombination of the two. The analyte detecting member may formed,configured, or shaped to receive fluid being spread off of the rib 1146.In some embodiments, there are no fluid bearing structures on theunderside of the cartridge.

FIG. 111 shows the underside of one embodiment of a cartridge 1152. Forease of illustration, the rib 1146 is made to appear thicker than it mayactually be. An thinned area 1154 is provided. The analyte detectingmember may be formed to occupy a portion of the area 1154correspondingto opening 1148 having rib 1146, formed to substantiallyfill the area 1154, formed to be placed against the surface 1154, orotherwise positioned to received fluid from openings 1148. In someembodiments, the analyte sensor forms the bottom surface of the chamber1150 and can be viewed as being one “wall” of that chamber. The analytedetecting member may be visible though the opening 1148 when thecartridge 1152 is assembled (and the sterility barrier is punctured). Avent channel 1156 may be configured, in some embodiments, to draw excessfluid towards the vent 1158 via an opening 1160. In other embodiments,the vent channel 1156 is not present and excess blood or fluid simplyfills the chamber 1150 or flows towards the narrowing 1162 (as seen inFIG. 10).

FIG. 112 shows an underside of a cartridge having two different fluidstructures which may be used, singly or in combination. The embodimenton the right includes an area 1164 that results due to reduction in sizeof opening 1166. The sizing of the opening 1166 may be controlleddepending on the amount of blood or fluid that the analyte detectingmember needs to perform its analysis. In various embodiments, this maybe less than about 1.0 μl, 0.9 μl, 0.8 μl, 0.7 μl, 0.6 μl, 0.5 μl, 0.4μl, 0.3 μl, 0.2 μl, 0.1 μl, 0.05 μl, or 0.01 μl.

FIG. 113 shows a top down view of one embodiment of a cartridge 1152according to the present invention. A rib 1146 is provided in chamber1150 to spread fluid to the analyte detecting members 1140, 1142, and1143. In this embodiment, the rib 1146 may be spaced apart from theanalyte detecting members 1140 and 1142, allowing fluid to flow betweenthe structures. In other embodiments, the analyte detecting members maybe flush against the rib 1146. In some embodiments, there are no fluidbearing structures on the underside of the cartridge. As a nonlimitingexample, the analyte detecting member used in the present embodiment canprovide its analysis using no more than about 1.0 μl, 0.9 μl, 0.8 μl,0.7 μl, 0.6 μl, 0.5 μl, 0.4 μl, 0.3 μl, 0.2 μl, 0.1 μl, 0.05 μl, or 0.01μl of fluid. In some embodiments, the amount of fluid used by allanalyte members associated with each sample chamber 1150 can provide itsanalysis using no more than about 1.0 μl, 0.9 μl, 0.8 μl, 0.7 μl, 0.6μl, 0.5 μl, 0.4 μl, 0.3 μl, 0.2 μl, 0.1 μl, 0.05 μl, or 0.01 μl offluid.

FIG. 114 is a close-up view of the embodiment of FIG. 114. A penetratingmember 1168 is shown in this view. In one embodiment, the penetratingmember 1168 may start in this position, in the chamber 1150 prior tolancing. The penetrating member 1168 may also return to this positionafter lancing. In still further embodiments, the penetrating member 1168may be advanced at a non-lancing speed to the position shown in FIG.114, stop, and then be actuated at lancing speeds to penetrate tissue.

FIG. 115 shows on embodiment of an underside to cartridge 1152. In thisembodiment, the analyte detecting members 1140, 1142, and 1143 are shownas they would be positioned in area 1154. Leads or connectors 1108 maybe coupled to the analyte detecting members. It should be understoodthat any of the analyte detecting members disclosed herein or known inthe art may adapted for use with the present invention.

Referring now to FIGS. 116 and 117, a still further embodiment of thepresent invention will now be described. In this embodiment of thecartridge, multiple fluid spreaders 1170 and 1172 are included forurging fluid into the various openings 1174, 1176, and 1178. In thisembodiment, the spreaders may be integrally formed with the cartridge.The analyte detecting members 1180 and 1182 in this embodiment areoriented perpendicularly to the openings 1174, 1176, and 1178.

Referring now to FIGS. 118 and 119, shows a variety of configurations ofcavities and openings for use with a cartridge according to the presentinvention. These configurations may be used singly or in combination ona cartridge. The cavities 1116 may have vent openings 1184 in locationsas shown in FIG. 118. Some embodiments may have a chamber 1150 with anextended configuration as seen in the embodiment associated withposition #4. In still further embodiments, the opening 1186 is notincluded and the only way to bring fluid to the underside is through oneof the openings 1184, which may be at any of the locations shown for thecavity 1116. In still further embodiments, the analyte detecting membermay be placed directly in the cavity 1116 without reliance on using aopening such as 1184 or 1186 to direct fluid to it. The analytedetecting member may be located anywhere in the cavity 1116 (on the sidesurfaces, bottom surfaces, etc).

FIG. 119 shows the underside configurations with numerals for eachcorresponding positions shown in FIG. 118. In the configurationassociation with position #3, the opening 1186 connects directly to theopen area 1188 which would correspond to the location of an analytedetecting member.

Referring now to FIG. 120, a still further embodiment of the presentinvention will now be described. This embodiment has a spreading element1190 which, along with at least one analyte detecting member underneaththe element 1190, forms the bottom wall of the chamber 1150. As anonlimiting example, the element 1190 may have a mesh, a weaver, or“chainmail” type configuration. As seen in the FIG. 120, the penetratingmember 1168 may have a start position in the chamber 1150. The spreadingelement 1190 may be made of a variety of materials, including but notlimited to, a nitrocellulose polymer, cellulose nitrate, hydrophobicporous versions of Nylon, polysulfone, and polycarbonates. Theseelements 1190 may be membranes in some embodiments and can often be castfrom a solution directly on the top of the sensing region. They may beconfigured morphologically in such a way as to wick blood exuding fromthe lancing site and direct the flow of the whole blood or the plasmacontent on to a sensor. The proposity control and surface treatment maybe varied to control the speed of flow (lateral or in through direction)or the rate of lateral spreading. Also they may be tailored to filterout particulates such as red blood cells. Additionally, the element 1190may be a polymer mixed in with the detection chemistry or other materialmixed in with detection chemistry. The element 1190 may occupy theentire area over the analyte sensor, a portion, some geometric shape(round, rectangular, square, shapes with openings, figure eights,crisscrossed, gridded, etc.), or any combination of one or more of theseconfigurations.

Referring now to FIGS. 121 and 122, a still further embodiment of acartridge according to the present invention will now be described. Thecartridge 1200 of FIG. 121 includes a plurality of notches 1202 formedin an opening 1204 in the cartridge. These notches 1202 may be used fora variety of purpose, including but not limited to, positioning of thecartridge 1200 in a lancing apparatus or for rotation purposes to changeposition of cavities 1116 aligned with a penetrating member launchingdevice. The hub (not shown) which would mate with the opening 1204 maybe rotating device that will be used to control which cavity 1116 andpenetrating member is positioned for engagement with the launcher.

In one embodiment, the cartridge 1200 may include front bearing areas1208 for guiding a penetrating member and rear bearing areas 1210. Therear bearing areas 1210 may be a length sufficient so that thepenetrating member may create a wound in the target tissue withoutlosing contact or guidance from the rear bearing area 1210. Thisprovides for more control of the cutting path taken by the penetratingmember. The cavity provides sufficient open space for a penetratingmember gripper to accommodate the throw distance used by the gripper toadvance the penetrating member to contact tissue. In some embodiments, amiddle guide bearing 1212 may be used. In such an embodiment, thegripper would grip a rear portion of the penetrating member, with bothbearings remaining in “front” of the gripper, and the throw area ofcavity 1116 moved towards at least the rear half (in one embodiment) ofthe cartridge as indicated by arrow 1213 in FIG. 123. As a nonlimitingexample, the throw distance may be adjusted as desired to take up morethan ½ of cavity 1116, less than ⅓, or less than ¼ of the cavity. Anarrowed portion 1218 may be included to hold the penetrating memberswhen the penetrating members are not being actuated.

As seen in FIG. 122, the portion 1220 on the cartridge 1200 may be openor pressed to close the top surface of the front bearing (while stillhaving an opening allowing the penetrating member to pass). There rearof cavity 1116 may be narrowed to hold the penetrating member in place.Portions 1222 may also be used to deal with flash associated with themanufacturing process.

Referring now to FIGS. 124 and 125, embodiments of the present inventionmay comprise kits containing any of the penetrating member actuators1230 disclosed herein. The kit may further include instructions for useIFU setting forth any of the methods described above. Optionally, thekit may further comprise a cartridge containing a plurality ofpenetrating members. The cartridge 1232 may be of any of the embodimentsdisclosed herein. Usually, the kit components will be packaged togetherin a pouch P or other conventional medical device packaging, such as abox, tray, tube, or the like. In many embodiments, the cartridge will bedisposable. The cartridge 1232 may itself be contained in a separatepouch or container and then inserted into the container P. In someembodiments, the IFU may be printed on the container P. In a nonlimitingexample, the container P may only contain an actuator 1230, without thecartridge 1232.

Referring now to FIG. 125, embodiments of the present invention mayinclude kits that only include a cartridge 1232. IFU may also beincluded. In some embodiments, a plurality of cartridges 1232 (shown inphantom) may be included. Any of the elements in these figures or otherelements described in this application may be placed in the container P,singly or in any combination.

While the invention has been described and illustrated with reference tocertain particular embodiments thereof, those skilled in the art willappreciate that various adaptations, changes, modifications,substitutions, deletions, or additions of procedures and protocols maybe made without departing from the spirit and scope of the invention.For example, with any of the above embodiments, the location of thepenetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). With any of the above embodiments, thepenetrating members may be a bare penetrating member during launch. Withany of the above embodiments, the penetrating members may be barepenetrating members prior to launch as this may allow for significantlytighter densities of penetrating members. In some embodiments, thepenetrating members may be bent, curved, textured, shaped, or otherwisetreated at a proximal end or area to facilitate handling by an actuator.The penetrating member may be configured to have a notch or groove tofacilitate coupling to a gripper. The notch or groove may be formedalong an elongate portion of the penetrating member. With any of theabove embodiments, the cavity may be on the bottom or the top of thecartridge, with the gripper on the other side. In some embodiments,analyte detecting members may be printed on the top, bottom, or side ofthe cavities. The front end of the cartridge maybe in contact with auser during lancing. The same driver may be used for advancing andretraction of the penetrating member. The penetrating member may have adiameters and length suitable for obtaining the blood volumes describedherein. The penetrating member driver may also be in substantially thesame plane as the cartridge. The driver may use a through hole or otheropening to engage a proximal end of a penetrating member to actuate thepenetrating member along a path into and out of the tissue.

Any of the features described in this application or any referencedisclosed herein may be adapted for use with any embodiment of thepresent invention. For example, the devices of the present invention mayalso be combined for use with injection penetrating members or needlesas described in commonly assigned, copending U.S. patent applicationSer. No. 10/127,395 filed Apr. 19, 2002. An analyte detecting member todetect the presence of foil may also be included in the lancingapparatus. For example, if a cavity has been used before, the foil orsterility barrier will be punched. The analyte detecting member candetect if the cavity is fresh or not based on the status of the barrier.It should be understood that in optional embodiments, the sterilitybarrier may be designed to pierce a sterility barrier of thickness thatdoes not dull a tip of the penetrating member. The lancing apparatus mayalso use improved drive mechanisms. For example, a solenoid forcegenerator may be improved to try to increase the amount of force thesolenoid can generate for a given current. A solenoid for use with thepresent invention may have five coils and in the present embodiment theslug is roughly the size of two coils. One change is to increase thethickness of the outer metal shell or windings surround the coils. Byincreasing the thickness, the flux will also be increased. The slug maybe split; two smaller slugs may also be used and offset by ½ of a coilpitch. This allows more slugs to be approaching a coil where it could beaccelerated. This creates more events where a slug is approaching acoil, creating a more efficient system.

In another optional alternative embodiment, a gripper in the inner endof the protective cavity may hold the penetrating member during shipmentand after use, eliminating the feature of using the foil, protectiveend, or other part to retain the used penetrating member. Some otheradvantages of the disclosed embodiments and features of additionalembodiments include: same mechanism for transferring the usedpenetrating members to a storage area; a high number of penetratingmembers such as 25, 50, 75, 100, 500, or more penetrating members may beput on a disk or cartridge; molded body about a lancet becomesunnecessary; manufacturing of multiple penetrating member devices issimplified through the use of cartridges; handling is possible of barerods metal wires, without any additional structural features, to actuatethem into tissue; maintaining extreme (better than 50 micron—lateral—andbetter than 20 micron vertical) precision in guiding; and storage systemfor new and used penetrating members, with individual cavities/slots isprovided. The housing of the lancing device may also be sized to beergonomically pleasing. In one embodiment, the device has a width ofabout 56 mm, a length of about 105 mm and a thickness of about 15 mm.Additionally, some embodiments of the present invention may be used withnon-electrical force generators or drive mechanism. For example, thepunch device and methods for releasing the penetrating members fromsterile enclosures could be adapted for use with spring based launchers.The gripper using a frictional coupling may also be adapted for use withother drive technologies.

Still further optional features may be included with the presentinvention. For example, with any of the above embodiments, the locationof the penetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). The penetrating members may be a barepenetrating member during launch. The same driver may be used foradvancing and retraction of the penetrating member. Different analytedetecting members detecting different ranges of glucose concentration,different analytes, or the like may be combined for use with eachpenetrating member. Non-potentiometric measurement techniques may alsobe used for analyte detection. For example, direct electron transfer ofglucose oxidase molecules adsorbed onto carbon nanotube powdermicroelectrode may be used to measure glucose levels. In someembodiments, the analyte detecting members may formed to flush with thecartridge so that a “well” is not formed. In some other embodiments, theanalyte detecting members may formed to be substantially flush (within200 microns or 100 microns) with the cartridge surfaces. In all methods,nanoscopic wire growth can be carried out via chemical vapor deposition(CVD). In all of the embodiments of the invention, preferred nanoscopicwires may be nanotubes. Any method useful for depositing a glucoseoxidase or other analyte detection material on a nanowire or nanotubemay be used with the present invention. Additionally, for someembodiments, any of the cartridge shown above may be configured withoutany of the penetrating members, so that the cartridge is simply ananalyte detecting device. Still further, the indexing of the cartridgemay be such that adjacent cavities may not necessarily be used seriallyor sequentially. As a nonlimiting example, every second cavity may beused sequentially, which means that the cartridge will go through tworotations before every or substantially all of the cavities are used. Asanother nonlimiting example, a cavity that is 3 cavities away, 4cavities away, or N cavities away may be the next one used. This mayallow for greater separation between cavities containing penetratingmembers that were just used and a fresh penetrating member to be usednext. This application cross-references commonly assigned copending U.S.patent applications Ser. No. 10/323,622 filed Dec. 18, 2002; commonlyassigned copending U.S. patent applications Ser. No. 10/323,623 filedDec. 18, 2002; and commonly assigned copending U.S. patent applicationsSer. No. 10/323,624 filed Dec. 18, 2002. This application is alsorelated to commonly assigned copending U.S. patent applications Ser.Nos. 10/335,142, 10/335,215, 10/335,258, 10/335,099, 10/335,219,10/335,052, 10/335,073, 10/335,220, 10/335,252, 10/335,218, 10/335,211,10/335,257, 10/335,217, 10/335,212, 10/335,241, 10/335,183, 10/335,082,10/335,240, 10/335,259, 10/335,182 filed Dec. 31, 2002. All applicationslisted above are fully incorporated herein by reference for allpurposes. Expected variations or differences in the results arecontemplated in accordance with the objects and practices of the presentinvention. It is intended, therefore, that the invention be defined bythe scope of the claims which follow and that such claims be interpretedas broadly as is reasonable.

1. A device for use with a body fluid sampling device for extractingbodily fluid from an anatomical feature, said device comprising: acartridge having a plurality of cavities; a plurality of penetratingmembers, at least one of said plurality of penetrating members beingcontained in one of said plurality of cavities of the cartridge, thepenetrating members being slidably movable to extend outward fromopenings on said cartridge to penetrate tissue; a plurality of analytedetecting members; a plurality of sample chambers, each associated withone of said cavities, said sample chambers being positioned along anouter periphery of said cartridge; wherein at least one of said analytedetecting members forms a portion of one wall of one of said pluralityof sample chambers; and a position sensor coupled to the plurality ofpenetrating members, and to a processor; the position sensor andprocessor measuring a distance from an initialization point to a pointof contact of a penetrating member to a target tissue surface, thepenetrating member being retracted by a drive force generator to theinitialization point with a distance to the target tissue being measuredand a depth of penetration of the penetrating member determined.
 2. Thedevice of claim 1 further comprising a fluid spreader positioned over atleast a portion of said analyte detecting member to urge fluid towardone of the detecting members.
 3. The device of claim 1 wherein saidpenetrating members each have a tip, wherein at least one tip has astarting position in one of said plurality of sample chambers.
 4. Thedevice of claim 1 wherein said analyte detecting members areelectrochemical.
 5. The device of claim 1 wherein at least one of saidsample chambers includes an opening on one of its surfaces, said openingleading fluid to an analyte detecting member.
 6. The device of claim 1wherein at least one of said sample chambers includes an opening on oneof its surfaces, wherein one of said analyte detecting members iscontained within said opening.
 7. The device of claim 1 wherein at leastone of said sample chambers includes an opening on one of its surfaces,wherein one of said analyte detecting members is visible through saidopening.
 8. The device of claim 1 wherein at least one of said samplechambers includes an opening on one of its surfaces, wherein one of saidanalyte detecting members is positioned so that the opening opensdirectly onto the detecting member.
 9. The device of claim 1 furthercomprising a mesh configured fluid spreader positioned over an analytesensing member.
 10. The device of claim 1 further comprising apenetrating member driver.
 11. A device for use with a body fluidsampling device for extracting bodily fluid from an anatomical feature,said device comprising: a cartridge having a plurality of cavities and aplurality of sample chambers; a plurality of penetrating members, atleast one of said plurality of penetrating members being contained inone of said plurality of cavities, the penetrating members beingslidably movable to extend outward from openings on said cartridge topenetrate tissue; a plurality of analyte detecting members positioned inthe plurality of sample chambers; wherein each of a sample chamber ispositioned substantially adjacent an outer periphery of said cartridge;wherein at least one of said analyte detecting members forms a portionof one wall of one of said plurality of sample chambers; and a positionsensor coupled to the plurality of penetrating members, the positionsensor measuring a distance from an initialization point to a point ofcontact of a penetrating member to a target tissue surface, thepenetrating member being retracted by a drive force generator to theinitialization point with a distance to the target tissue being measuredand a depth of penetration of the penetrating member determined.
 12. Thedevice of claim 11 further comprising a plurality of ribs, eachassociated with one of said sample chambers.
 13. A device for use with abody fluid sampling device for extracting bodily fluid from ananatomical feature, said device comprising: a cartridge having aplurality of sample chambers; a plurality of penetrating members, atleast one of said plurality of penetrating members being contained insaid cavities each of a penetrating member being slidably movable toextend outward from an opening on said cartridge to penetrate tissue; aplurality of analyte detecting members; wherein each of a sample chamberbeing positioned substantially adjacent an outer periphery of saidcartridge; at least one opening in one of said sample chambers leadingfluid along a fluid path towards one of said analyte detecting members;and a position sensor coupled to the plurality of penetrating members,the position sensor measuring a distance from an initialization point toa point of contact of a penetrating member to a target tissue surface,the penetrating member being retracted by a drive force generator to theinitialization point with a distance to the target tissue being measuredand a depth of penetration of the penetrating member determined.
 14. Thedevice of claim 13 wherein said fluid path contains a channel sized tohold no more than 1 microliter.